To evaluate the 12-month efficacy and safety of open bleb revision (OBR) for Preserflo® MicroShunt (PMS) (Santen, Osaka, Japan) bleb failure. All consecutive patients who underwent PMS OBR for primary bleb failure between April 2019 and July 2024 at the Hôpital National des Quinze-Vingts (Paris, France) were retrospectively included. The primary endpoint was assessed at 6 and 12 months as surgical success, defined as an intraocular pressure (IOP) ≤ 21 mmHg with a ≥ 20 What is new?

Background/Objectives: Glaucoma is a leading cause of irreversible blindness, and lowering intraocular pressure (IOP) is the only proven strategy to slow disease progression. The Preserflo® Microshunt (PMS) is a minimally invasive subconjunctival drainage device used to treat uncontrolled glaucoma. Given that cataracts and glaucoma often coexist, this study aimed to compare the 12-month efficacy and safety of PMS implanted as a standalone procedure versus combined with phacoemulsification (PCE). Methods: This single-center retrospective case-control study included 104 eyes (26 PMS + PCE; 78 standalone PMS) from patients treated between 2019 and 2023. Controls were matched 3:1 to cases on sex, age, glaucoma severity, baseline IOP, and number of prior glaucoma surgeries. Success at 12 months was defined as absolute (IOP ≤ 21 mmHg without medications) or qualified (IOP ≤ 21 mmHg with the same or fewer medications). Secondary outcomes included changes in IOP, medication burden, and safety profiles. Results: At 12 months, absolute success was achieved in 23.1% of the PMS + PCE group versus 43.6% in the standalone PMS group (p = 0.13). However, the Kaplan-Meier survival probability of absolute success was significantly higher for standalone PMS (75.2% vs. 40.2%, p = 0.0028). Qualified success rates were comparable (53.9% vs. 70.5%, p = 0.30). Both groups showed similar reductions in mean IOP and medication counts. Although safety profiles were comparable, the mean time to first bleb revision (p = 0.031) and first needling (p = 0.015) was significantly shorter in the combined group. Conclusions: Both standalone and combined PMS procedures are effective and safe in achieving sustained IOP reduction. Although standalone implantation appears to be associated with higher medication-free success rates, combined surgery remains a reasonable option for patients with coexisting cataract, despite a tendency toward earlier bleb fibrosis likely related to the inflammatory response induced by PCE.

We report a patient with isolated ptosis secondary to orbital metastasis but no evidence of a neoplastic process on magnetic resonance imaging (MRI). A 69-year-old male was referred to our hospital with ptosis of the right upper eyelid and secondary frontalis muscle overaction on the left side for six months. The palpebral fissure was 3mm on the right and 16mm on the left, and levator function was 6mm and 19mm respectively. Three years previously, he had undergone surgical resection of the left lower lobe of the lung due to a T1 N0 M0 adenocarcinoma, and no recurrence had since been observed. An MRI was performed to rule out ptosis secondary to metastasis. Thyroid dysfunction and myasthenia were also ruled out. The ptosis was attributed to an isolated microvascular third nerve palsy. A standard external levator advancement was performed. Six months after the surgery, the patient presented with intense pain, minimal ptosis, edema and diplopia. A new MRI revealed an orbital metastasis measuring 2.4×1.0×1.6cm in the superior orbit, exerting mass effect on the superior rectus and the levator palpebrae superioris muscle. A positron emission tomography scan revealed a recurrence of the lung cancer with multiple bony metastases. The patient underwent chemotherapy consisting of the taxol-carboplatin protocol. Our report highlights the importance of a high index of suspicion of a neoplastic etiology in patients with mild symptoms and a history of cancer even if imaging does not initially reveal a mass or infiltration.

Periorbital necrotising cellulitis is a rare localisation of fasciitis and an exceptional complication of cosmetic blepharoplasty. We discuss here the case of a 52-year-old woman who presented with orbital cellulitis 2 days after undergoing a bilateral cosmetic lower blepharoplasty. The diagnosis was confirmed on magnetic resonance imaging. Cellulitis was complicated by ocular hypertension resistant to local treatment and intravenous acetazolamide, leading to a decrease in visual acuity. Infection management consisted of intravenous antibiotics, corticosteroid bolus and drainage surgery. Bacteriological samples yielded Staphylococcus epidermidis resistant to all betalactamines. Anatomopathological analysis of the drained sample revealed an aspect compatible with necrotising cellulitis. To our knowledge, this is the seventh case of necrotising cellulitis occurring after blepharoplasty reported in the literature. The other cases were due to the virulent Streptococcus pyogenes and required surgical debridement and antibiotics. Our case is unique, as it is the first reported case of necrotising cellulitis due to another pathogen, Staphylococcus epidermidis, which appears less virulent.

INTRODUCTION:Solitary fibrous tumor (SFT) is a rare borderline mesenchymal tumor typically arising in the pleura and involving the orbit as its most common extra-pleural location. CASE DESCRIPTION:We herein describe two cases of orbital SFT arising in both a 69-year-old woman presenting with progressive proptosis of the left eye and a 49-year-old woman presenting with binocular diplopia. The diagnoses relied on histopathological analysis of biopsy samples. Because of the poor local prognosis, we decided to perform an orbital exenteration in the first case. In the second case, a complete resection surgery was performed. CONCLUSION:SFT presents classics histological features and immunohistochemical markers that are essential to the diagnosis. SFT is classified as a benign tumor, but in some cases, it can show aggressive behavior with the potential for local tissue invasion and, more scarcely, distant metastasis. This is why complete resection remains the treatment of choice for SFT.

PURPOSE:The goal of this study is to examine changing patterns of ophthalmic visits in an emergency eye care unit of a tertiary referral center in Paris, France, during the Coronavirus disease-19 (COVID-19) pandemic compared to a control period.MATERIALS AND METHODS:This was a single-center, retrospective, observational, epidemiological study. We included all visits in the emergency eye care unit of the Quinze-Vingts National Ophthalmology Center, Paris, France, from March 17, 2020 to April 30, 2020, and a corresponding time period in 2016. We analyzed patients' demographic factors, chief complaints, referral patterns, examination findings, treatment provided, hospitalizations and surgical interventions.RESULTS:During the 6weeks of lockdown, 3547 emergency visits were recorded. The control group contained 2108 patients from June 6-19, 2016. There was a decrease of approximately 50% in the number of average daily visitations. The frequency of serious diagnoses (including severe eye inflammation, serious infections, retinal vascular pathologies, surgical emergencies, and neuro-ophthalmology), increased overall during the period (P=0.03). The proportion of low severity pathologies decreased (P<0.001) between the two periods. In addition, an increased amount of ancillary testing was performed (P<0.001). Finally, the rate of hospitalizations was significantly lower during the lockdown period (P<0.001).CONCLUSION:A significant reduction in total ophthalmic presentations in the emergency eye care unit was observed during the lockdown period. However, the proportion of emergencies requiring specialized treatments (surgical, infectious, inflammatory and neuro-ophthalmological pathologies) increased.

Purpose. - To compare the refractive outcomes of sutureless scleral-fixated Carlevale (R) intraocular lenses versus Artisan (R) iris-claw-fixated tenses in terms of surgically induced astigmatism. Setting. - We included patients from the Quinze-Vingts National Ophthalmology Hospital, Paris, from August 2020 to December 2020. Design. - This was a single-center retrospective study. Methods. - Each patient included had undergone surgery with a sutureless scleral-fixated Carlevale (R) foldable intraocular lens or an Artisan (R) iris-claw lens in the context of secondary implantation. Exclusion criteria included a history of retinal detachment or any other retinal disease. We analyzed postoperative refractive data three months after surgery for the Carlevale group and three months after removal of all sutures for the Artisan group. Results. - A total of 25 eyes of 25 patients were included in the Carlevale group and 37 eyes of 36 patients in the Artisan group. At three months, the best-corrected visual acuity was not statistically different, at 0.33(+/- 0.35) and 0.32(+/- 0.33) LogMAR, respectively (P= 0.99), and surgically induced astigmatism was significantly lower in the Carlevale group, at 0.538 (+/- 0.560) and 2.30 (+/- 3.97) Diopters, respectively (P<0.001). Conclusions. - In this first comparative study, Carlevale (R) intraocular lenses appear to offer better refractive accuracy and less induced astigmatism than Artisan (R) iris-claw lenses, without increasing mean surgical time. (C) 2022 Published by Elsevier Masson SAS.

Purpose Facial nerve paralysis (FNP) may result in a range of ocular sequelae. Lower eyelid retraction and paralytic ectropion due to FNP contributes to lagophthalmos and sight-threatening exposure keratopathy. The pathophysiology of lower eyelid retraction secondary to FNP involves lateral canthal tendon laxity, middle lamella defect, and malar descent. The aim of this study is to describe a series of patients with FNP whose lid retraction was treated with a combined dermis spacer graft, lateral canthopexy and subperiosteal midface lifting. Methods The study design was a retrospective non-comparative case series from January 2018 to August 2019. Only consecutive patients with moderate to severe lower eyelid retraction secondary to chronic FNP (over 1 year) were included. Preoperatively, all patients were noted to have a combination of lower eyelid laxity, middle lamellar contracture, and malar descent. All patients underwent a triple procedure including a dermis spacer graft, lateral canthopexy and subperiosteal midface lifting. Preoperative and postoperative assessment included evaluation of lower eyelid position, lagophthalmos, midfacial ptosis and facial asymmetry. Follow-up was at 1 week, 1 month and 12 months, postoperatively. Results All 3 patients (representing 3 retracted eyelids) had complete resolution of scleral show and were uniformly satisfied with their cosmetic and functional outcome at last follow up. Preoperative dry eye symptoms resolved in all patients in the series. There were no major complications. Conclusion The combination of dermis spacer grafting, lateral canthopexy, and midface lifting is an effective, esthetic, and functional treatment for lower eyelid retraction resulting from FNP. This procedure is associated with a low morbidity rate, and high patient satisfaction. This technique treats the three pathophysiologic components (posterior, intermediate and anterior lamella defect) simultaneously and rehabilitates the patients cosmetically and functionally.

Purpose: The purpose of this study was to assess cryopreserved amniotic membrane (C-AM) versus chorion-free freeze-dried amniotic membrane (FD-AM) overlay transplantation for corneal ulcers in a French tertiary ophthalmology hospital. Methods: Between March and July 2020, when C-AMs were not available because of the COVID-19 pandemic, 28 corneal ulcers underwent FD-AM overlay transplantation and were retrospectively compared with 22 corneal ulcers treated with C-AM during the same period in 2018. All patients had at least 3 months of follow-up, and those who underwent combined surgeries were excluded. Ulcers were assessed at baseline and then at 72 hours, 1 month, and 3 months. Population demographics, follow-up time, ulcer etiologies, epithelial defect size, ulcer depth, and complications were also recorded. Results: Baseline characteristics and clinical features of both groups were comparable. There was no statistically significant difference in the number of overlay AM transplantations ( P = 0.52) or early detachments ( P = 0.57). At 3 months, the corneal healing rate was almost the same in both groups (89% and 91% for FD-AM and C-AM, respectively; P = 0.87). Complications were equally uncommon (11% and 9%, respectively; P = 0.92). In logistic regression, the type of the membrane did not influence corneal healing at 1 month ( P = 0.42) or 3 months ( P = 0.99), regardless of the depth of the ulcer. However, whatever the type of AM used, the deeper the ulcer was, the less likely it was to heal at 3 months ( P = 0.02). Conclusions: This is the first study that provides positive insight into the effectiveness of FD-AM compared with C-AM when used as overlay transplantation for treating corneal ulcers.

The aim of this study is to report a case of bilateral traumatic maculopathy in a 19-year-old male following blunt trauma during 2020 coronavirus disease-2019 national lockdown. Descriptive case report based on data from clinical records, patient observation, and analysis of diagnostic tests. A previously healthy, 19-year-old male presented for a visit in our department at 15–20 National Ophthalmology Institute with complaints of bilateral decreased visual acuity. A history of recent blunt trauma caused by resistance band was reported. Fundus examination recorded fibrosis and inferior preretinal hemorrhages on both eyes. Peripheral retinal examination was normal. Optical coherence tomography showed bilateral increased reflectivity, disruption of the inner/outer segment, and loss of the external limiting membrane. The 6-week follow-up did not show a major recovery. Early detection of posterior segment damage after blunt trauma remains primordial despite worldwide pandemic.

Aims To determine anterior chamber tap cytology characteristics in acute postoperative bacterial endophthalmitis. Methods 488 eyes of 488 patients were included in this retrospective case–control study. The study group included 93 eyes with bacteriologically documented endophthalmitis and 85 eyes with clinical endophthalmitis. The control group included 33 eyes with non-infectious postoperative inflammation, 116 eyes with acute uveitis and 161 cataract surgery eyes with no ocular inflammation. Cytological analysis, direct examination and microbiological cultures were performed in aqueous humour (AqH) samples. Inclusion criteria for the study group were the following: suspected endophthalmitis within 30 days following cataract surgery by phacoemulsification, secondary lens implantation, pars plana vitrectomy or intravitreal injection; best-corrected visual acuity (BCVA) <20/400; hypopyon or cyclitic membrane; absence of visibility of the retina; vitritis at a slit-lamp examination or in ultrasound B-scan. Results Cell line counts (mainly polymorphonuclear neutrophils) were significantly higher in the two endophthalmitis study subgroups than in the three control subgroups. The study group showed a predominance of polymorphonuclear neutrophils as opposed to the three control subgroups including uveitis (p<0.00001). The best sensitivity/specificity was obtained using a polymorphonuclear neutrophil threshold of 10 per field (sensitivity, 0.90; specificity, 0.75). The sensitivity of the bacterial culture was 32% in the AqH. High neutrophil count was associated with poorer initial BCVA (r s =0.62; p<0.00001) and higher risk of retinal detachment during (p=0.04) and after (p<0.001) hospitalisation. Conclusion Anterior chamber tap cytology is a quick and accessible tool complementary to culture and PCR for the management of acute postoperative endophthalmitis.

The aim of this study was to compare surgical outcomes and postoperative characteristics, between eyes that underwent pars plana vitrectomy (PPV) for RRD, with air or different gas agents as tamponade.The records of 262 patients that underwent PPV for RRD with air or different gas tamponades and a follow-up of at least 6 months were examined. Only cases with superior retinal breaks were included. Demographic, pre-, intra- and postoperative characteristics including rate of recurrence and complications were analysed.48 patients were treated with air and 214 were treated with gas. No differences were found in success rate between air and gas group at both 3 and 6 months (respectively, 93.8% vs 93.6 and 100% vs 100%, all P values > 0.05). Postoperative best-corrected visual acuity (BCVA) was significantly higher in the air group compared with the gas group 7 days and 1 month postoperatively (respectively, 0.2 ± 0.4 vs 2.6 ± 0.5, P < 0.001 and 0.1 ± 0.4 vs 0.4±0.9, P = 0.04). The occurrence ocular hypertension at 1 month postoperatively was significantly higher in the gas group compared with the air group (15.4 % vs 0%, P < 0.001). At 6 months, the prevalence of epiretinal membrane (ERM) was significantly higher in the gas group compared with air group (4.2% vs 16.8%, P = 0.02).Air was comparable to gas tamponades in terms of surgical outcome and BCVA at 6 months. In addition, air allowed an earlier visual recovery and resulted in a lower rate of postoperative ocular hypertension and ERM.

Objective: To assess the reduction in IOP and ocular symptoms in patients newly diagnosed with POAG and treated with latanoprost as monotherapy. Patients and method: A multicentric, cross-sectional, descriptive study was conducted. We included adults newly diagnosed with POAG. All patients received one drop of preserved latanoprost 0.005% in each eye every night for 12 weeks. Changes in IOP and ophthalmic signs and symptoms were assessed during and at the end of treatment. Results: A total of 524 patients were included, with a participation rate of 93% at 12 weeks. The mean age was 52.79 +/- 17.33 years, and the sex ratio M/F was 1.39. At inclusion, the mean IOP was 21.68 +/- 9.72 mmHg. After 2 weeks of treatment, the mean IOP was 15.49 +/- 5.81 mmHg, for a reduction of 28.55%. After 12 weeks of treatment, the mean IOP was 13.16 +/- 3.54 mmHg, for a reduction of 39.30%. The main symptom recorded was a gritty foreign body sensation, the frequency of which was 4.72% at W2 and 2.45% at W12. The main sign was hyperemia (4.33% at W2 and 1.84% at W12). Conclusion: Latanoprost given as first-line monotherapy in POAG in blacks considerably reduces IOP. The incidence of side effects remains low; it is higher at the start of treatment. (C) 2021 Elsevier Masson SAS. All rights reserved.

PURPOSE:To report an epidemiological update of documented fungal keratitis (FK) in a French tertiary ophthalmological centre from 2014 to 2018 in comparison with a previous period from 1993 to 2008.METHODS:Sixty-two consecutive FK documented by microbiological corneal scrapings were compared with the 64 FK of the previous study. Amphotericin B and voriconazole eye drops were administered hourly. Population characteristics, clinical findings, aetiological organisms and treatments were analysed.RESULTS:The most frequently identified fungi were Fusarium (61%), Aspergillus (6.5%) and Candida (5%). Thirty out of 44 cases examined with in vivo confocal microscopy (IVCM) presented filaments. Ten required conventional cross-linking, 9 therapeutic penetrating keratoplasty, and 2 enucleation. Risk factors significantly associated with the absence of response to medical treatment were patient age (p = 0.01), presence of a deep stromal infiltrate at presentation (p = 0.04) and high numbers of filaments in IVCM images (p = 0.01). The two populations were comparable in age, but not in sex ratio males/females (18/44 versus 37/26 in the previous study; p = 0.001). The frequency of contact lens-associated infection increased from 35.5% to 71% (p = 0.0001) between the two periods. Since then, filamentous FK increased from 69% (44/64) to 95% (59/62) (p = 0.0001). A history of keratoplasty was less frequently reported during the last period (3.2% (2/62) versus 17% (11/64) of cases (p = 0.01)). A clear decrease in the frequency of therapeutic keratoplasty was noted from 39% (25/64) to 14% (9/62) (p = 0.02).CONCLUSION:The frequency of filamentous keratomycosis is currently increasing. Elderly patients and the presence of numerous filaments in IVCM are associated with poor clinical outcomes.

Abstract Background To compare the efficacy of phacoemulsification (PKE) combined with nonpenetrating deep sclerectomy (NPDS) with mitomycin C (MMC) versus XEN® gel stent with MMC. Methods In this nonrandomized, retrospective, comparative, single-center pilot study, 105 consecutive eyes of 75 patients with uncontrolled primary open-angle glaucoma (POAG) and cataract who underwent PKE combined with either XEN implantation (n = 47) or NPDS (n = 58) between May 2013 and November 2018 were included. The primary outcome was complete success at 9 months, which was defined as intraocular pressure (IOP) ≤18, 15 or 12 mmHg without treatment; qualified success was IOP ≤18, 15 or 12 mmHg with antiglaucoma medications. Secondary outcome measures included the number of antiglaucoma medications, visual acuity (VA), and postoperative adverse events. Results Using the 18 mmHg threshold, complete or qualified success was achieved in 69.6 and 89.1% in the PKE + XEN group, and 63.8 and 89.7% in the PKE + NPDS group (p = .54 and p = .93), respectively, at 9 months. The mean IOP decreased from 20.8 ± 6.8 mmHg to 16.2 ± 2.8 mmHg in the PKE + XEN group (p < .001, 18.9% mean drop), and from 21.5 ± 8.9 mmHg to 14.9 ± 3.9 mmHg in the PKE + NPDS group (p < .001, 25.6% mean drop). Best-corrected VA significantly improved (p < .001) in both groups. The mean number of antiglaucoma medications was significantly reduced from 2.66 ± 1.1 to 0.49 ± 1.0 in the PKE + XEN group (p < .001) and from 2.93 ± 0.9 to 0.69 ± 1.2 in the PKE + NPDS group (p < .001). Conclusions The XEN stent combined with PKE seemed to be as effective and safe as PKE + NPDS at 9 months in this pilot study.

PURPOSE To report the clinical results of lens capsular flap (LCF) transplantation in a patient with refractory medium macular hole (MH). METHODS Case report. RESULTS A 66-year-old female myopic patient with a history of medium macular hole (MH) was previously unsuccessfully treated by vitrectomy surgery, internal limiting membrane (ILM) peeling and air-fluid exchange followed by 12% C2F6 tamponade into the vitreous cavity and face-down positioning. After the first surgery, the patient's visual acuity of the left eye remained only 20/400 on the Snellen scale, and a persistent medium MH (290 µm) was observed on optical coherence tomography. Cataract of the left eye was also noted. A second surgery, combined cataract-vitrectomy surgery, was carried out to seal the MH, performed under retrobulbar anesthesia. Because there was insufficient ILM tissue to perform the ILM flap procedure, we decided to use another technique involving an autologous LCF. The patient underwent LCF placement onto the MH along with gas tamponade. At 6 months, the MH was sealed, and the patient's vision had improved to 20/32 on the Snellen scale. CONCLUSION This is the first case report to describe the use of LCF to treat persistent medium MH. LCF seems to be effective in sealing small macular holes and was well tolerated by the patient.

PURPOSE:Iris intraocular implants were developed to manage congenital or traumatic iris defects. However, they are also used to change the color of patient eyes. The aim of this retrospective series was to report complications in patients managed in France after cosmetic implantation.SETTING:Ophthalmological institutions and private ophthalmologists in France.DESIGN:Multicenter retrospective observational study.METHODS:Questionnaires were sent to all ophthalmology departments in university hospitals and to private ophthalmologists. This questionnaire listed demographic and clinical data for each implanted eye with a focus on safety, the description of ocular complications (corneal edema, endothelial cell loss, increased intraocular pressure, and intraocular inflammation), and the therapeutic management implemented.RESULTS:Forty-four questionnaires (87 eyes) were collected, and ultimately, 33 questionnaires (65 eyes) were considered complete and analyzed. Two types of implants were identified. Of the 65 eyes analyzed, only 5 eyes (7.7%) did not experience any complication and 60 eyes (92.3%) had at least 1 complication. The most commonly reported complication was corneal decompensation (78.5%). The diagnosis of glaucoma was made in over half (52.3%) of the cases. Explantation was needed in 81.5% of cases. The mean final visual acuity was 0.45 ± 0.08 logarithm of the minimum angle of resolution (logMAR) (0 to 2 logMAR).CONCLUSIONS:Several ocular complications with a decreased mean visual acuity were described in a young healthy population. In addition, patient information on the safety of this procedure appeared insufficient.

Introduction. To assess the safety and efficacy of selective laser trabeculoplasty (SLT) for ocular hypertension (OHT) induced by a dexamethasone (DEX) intravitreal implant. Materials and Methods. We performed a retrospective study of patients who underwent an SLT procedure for ocular hypertension induced by injection of a DEX intravitreal implant. Patients had, at least, one injection of the DEX-implant for symptomatic macular edema. SLT was delivered to 360° of the trabecular meshwork in two sessions. The primary outcome was a decrease in IOP, evaluated at one, three, and six months after the SLT procedure. Results. Twenty-six eyes of 22 patients were included. The mean intraocular pressure (IOP) measured after DEX-implant injection was 25.4 ± 5.4 mmHg, and the mean increase in IOP was 35.8 ± 14.6%. The mean follow-up after SLT was 18.3 ± 7.7 months. After SLT, the mean IOP dropped by 30.9% at one month (16.9 ± 4.5 mmHg, p = 0.01 ), 33.6% at three months (16.0 ± 2.7 mmHg, p < 0.01 ), and 34.9% at six months (15.6 ± 2.1 mmHg, p < 0.01 ). Each patient had a minimum follow-up of 6 months after SLT. Eight eyes (31%) received a second DEX-implant injection after the SLT procedure without experiencing an increase in the IOP above 21 mmHg or >20%. No glaucoma surgery was required during the follow-up. The mean number of medications (1.65 ± 1.36) was significantly reduced at one (1.19 ± 1.20, p = 0.04 ), three (0.96 ± 1.03, p < 0.01 ), and six months (0.77 ± 0.95, p < 0.01 ) after SLT. Conclusion. SLT is an effective and safe procedure to control OHT following DEX-implant intravitreal injection.

PRECIS Non-inferiority of efficacy was demonstrated for a preservative-free latanoprost-timolol fixed combination compared to a BAK-containing formulation at 84 days after treatment in patients with open-angle glaucoma or ocular hypertension. PURPOSE To compare the effect on intraocular pressure and safety of preservative-free latanoprost-timolol fixed combination (T2347) to benzalkonium chloride-preserved latanoprost-timolol fixed combination in patients with open-angle glaucoma or ocular hypertension. METHODS Phase III,randomizedd, parallel-group, investigator-masked study in 10 countries. A total of 242 patients aged ≥18 years with open-angle glaucoma or ocular hypertension in both eyes controlled with a preserved latanoprost-timolol fixed combination (15.7±2.4▒mm Hg overall prior to inclusion) were randomised at Day 0 with no washout period to receive the preservative-free alternative T2347 (N=127) or remain on the preserved comparator (N=115) for 84 days. Intraocular pressure changes from Day 0 were measured at 9:00 am (+/-1 hour) on Day 42 and Day 84, and non-inferiority of T2347 to the preserved comparator wasanalyzedd statistically at Day 84. Safety parameters were also reported. RESULTS The mean change in intraocular pressure from baseline to Day 84 was -0.49±1.80▒mm Hg for preservative-free T2347 and -0.49±2.25▒mm Hg for the preserved comparator. These results met the non-inferiority limits. Similar results were observed at Day 42. There was no difference between groups in the incidence of adverse events or ocular signs. The total ocular symptoms score was better for T2347 than BPLT upon instillation at Day 84 (45.9%/44.3%/9.8% patients with improvement/no change/worsening versus 33.6%/47.3%/19.1%; P=0.021), reflecting improvements in individual symptoms such as irritation/burning/stinging (P<0.001) and itching (P<0.01) on Day 84. CONCLUSION Preservative-free latanoprost-timolol fixed combination T2347 showed non-inferior efficacy compared to the preserved comparator and was well tolerated.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0/.