PURPOSE:To report the first known use of combined decellularized Descemet membrane anterior keratoplasty with penetrating keratoplasty (PKP) in a pediatric patient. METHODS:A 2-month-old boy with bilateral sclerocornea underwent bilateral sequential PKP. In the left eye, PKP performed at 2 months of age was complicated by a persistent epithelial defect postoperatively with a 1 month delay in epithelialization. As a result, the patient underwent PKP with a combined decellularized Descemet membrane corneal allograft implantation in the right eye at 3 months of age to enhance early postoperative healing. This was performed by creating a central 3-mm superficial keratectomy before placing Descemet membrane allograft onto the full-thickness graft. RESULTS:Compared to the 1-month delay in epithelialization after PKP in the left eye, the right eye, which underwent combined PKP and decellularized Descemet membrane corneal allograft, was fully epithelialized by the first postoperative week. The grafts remain clear and intact at 12 months of age. The patient exhibited significant improvement in visual behavior. CONCLUSIONS:This case highlights the successful use of decellularized Descemet membrane anterior keratoplasty in preventing a persistent epithelial defect in the early postoperative period for a pediatric patient with sclerocornea. This may be a viable option for similar pediatric cases with delayed epithelial healing while promoting graft survival and minimizing the need for additional surgical interventions.
BackgroundDry eye disease (DED) is commonly caused by excessive tear film evaporation due to Meibomian gland dysfunction (MGD). There is a need for DED treatment options that address tear evaporation and benefit patients across a broad range of demographic and disease characteristics. This study evaluated treatment effects of perfluorohexyloctane ophthalmic drop (formerly NOV03) in the pooled dataset from 2 pivotal clinical trials in patients with DED associated with MGD, both in the overall population and in patient subgroups based on sex, age, and baseline severity of eye dryness.MethodsPooled data from 2 similarly designed, phase 3, randomized controlled trials (GOBI, MOJAVE) were analyzed. Patients aged ≥18 years with DED administered perfluorohexyloctane (n=614) or hypotonic (0.6% solution) saline control (n=603) four times daily for 8 weeks. Primary endpoints were total corneal fluorescein staining (tCFS) score (National Eye Institute scale, 0-15) and eye dryness visual analog scale (VAS) score (0-100). Efficacy was evaluated using analysis of covariance among patient subgroups (male and female, older [≥65 years] and younger [18 to <65 years], tCFS score <7 and ≥7, VAS eye dryness score <70 and ≥70, MGD score <7 and ≥7, Schirmer I test <10 mm and ≥10 mm).ResultsReductions in tCFS and VAS eye dryness scores were greater for perfluorohexyloctane versus control. In the overall patient population, least-squares mean treatment difference was −1.1 (95% CI: −1.41 to −0.79; p<0.0001) for tCFS and −9.0 (95% CI: −11.90 to −6.00; p<0.0001) for VAS eye dryness. Treatment favored perfluorohexyloctane over control in all patient subgroup analyses of tCFS and VAS eye dryness. Overall, the most common adverse event with perfluorohexyloctane was blurred vision (2.1% of patients), which was mild and transient.ConclusionsCompared with a hypotonic saline control, perfluorohexyloctane improved both the signs and symptoms of DED, including in patients with greater self-reported severity of eye dryness.Clinical trial registrationThis study represents an integrated analysis of 2 previous clinical trials: GOBI (ClinicalTrials.gov, NCT04139798) and MOJAVE (ClinicalTrials.gov, NCT04567329).
Purpose: To evaluate the efficacy and safety of NOV03 (perfluorohexyloctane) ophthalmic drop in patients with dry eye disease (DED) associated with meibomian gland dysfunction (MGD). Participants: Adults > 18 years with a history of DED for > 6 months, tear film breakup time of < 5 seconds, Schirmer I test (without anesthesia) score > 5 mm, MGD score > 3 (0-15 scale), and total corneal fluorescein staining (tCFS) score > 4 and < 11 (0-15 National Eye Institute [NEI] scale). Methods: Patients were randomized 1:1 to NOV03 or hypotonic (0.6%) saline 4 times daily. Main Outcome Measures: The primary sign and symptom end points were change from baseline in tCFS and eye dryness score (0-100 visual analog scale [VAS]) at week 8. Key secondary end points were change from baseline in eye dryness score at week 2, tCFS at week 2, eye burning or stinging score (0-100 VAS) at week 8, and central corneal fluorescein staining (cCFS; 0-3 NEI scale) at week 8. Results: Of the 599 patients randomized, 597 were treated (NOV03, n = 303; saline, n = 294). At week 8, improvement from baseline was significantly greater (P < 0.001) with NOV03 versus saline for tCFS (least square [LS] mean treatment difference, -0.97; 95% confidence interval [CI]: -1.40, -0.55) and VAS dryness score (-7.6; 95% CI: -11.8, -3.4). Improvement from baseline also significantly (P < 0.01) favored NOV03 on all key secondary end points: LS mean treatment difference (95% CI) was -4.7 (-8.2, -1.2) for VAS dryness score at week 2, -0.6 (-0.9, -0.2) for tCFS at week 2, -5.5 (-9.5, -1.6) for VAS burning or stinging score at week 8, and -0.2 (-0.4, -0.1) for cCFS at week 8. Most ocular adverse events (AEs) were mild in severity; no serious ocular AEs occurred. One patient discontinued NOV03 because of an AE (eye irritation). Conclusions: In patients with DED associated with MGD, NOV03 demonstrated statistically significant and clinically meaningful improvements versus hypotonic saline in signs and symptoms of DED and was well tolerated. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references. Ophthalmology 2023;130:516-524 (c) 2023 by the American Academy of Ophthalmology. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
