To evaluate the efficacy and safety of topical cenegermin (recombinant human nerve growth factor) in patients with neurotrophic keratopathy.Design: Multicenter, randomized, double-masked, vehicle-controlled trial.Participants: Patients with neurotrophic persistent epithelial defect with or without stromal thinning. Methods: The NGF0214 trial, conducted among 11 sites in the United States, randomized 48 patients 1:1 to cenegermin 20 mg/ml or vehicle eye drops, 6 drops daily for 8 weeks of masked treatment. Follow-up was 24 weeks. Safety was assessed in all patients who received study drug. Efficacy was assessed by intention to treat. Main Outcome Measures: The primary end point was healing of the neurotrophic lesion (persistent epithelial defect or corneal ulcer) after 8 weeks of masked treatment. Masked central readers measured neurotrophic lesions in randomized clinical pictures, then assessed healing status conventionally (<0.5 mm of fluorescein staining in the greatest dimension of the lesion area) and conservatively (0-mm lesion staining and no other residual staining). Secondary variables included corneal healing at 4 weeks of masked treatment (key secondary end point), overall changes in lesion size, rates of disease progression, and changes in visual acuity and corneal sensitivity from baseline to week 8.Results: Conventional assessment of corneal healing showed statistically significant differences at week 8: compared to 7 of 24 vehicle-treated patients (29.2%), 16 of 23 cenegermin-treated patients (69.6%) achieved less than 0.5 mm of lesion staining (þ40.4%; 95% confidence interval [CI], 14.2%e66.6%; P ¼ 0.006). Conservative assessment of corneal healing also reached statistical significance at week 8: compared to 4 of 24 vehicle-treated patients (16.7%), 15 of 23 cenegermin-treated patients (65.2%) achieved 0 mm of lesion staining and no other residual staining (þ48.6%; 95% CI, 24.0%e73.1%; P < 0.001). Moreover, the conservative measure of corneal healing showed statistical significance at week 4 (key secondary end point). Compared to vehicle, cenegermintreated patients showed statistically significant reductions in lesion size and disease progression rates during masked treatment. Cenegermin was well tolerated; adverse effects were mostly local, mild, and transient.Conclusions: Cenegermin treatment showed higher rates of corneal healing than vehicle in neurotrophic keratopathy associated with nonhealing corneal defects.
Treating cataract blindness worldwide continues to be a formidable challenge. Significant barriers include cost, lack of population awareness, shortage of trained personnel and poor surgical outcomes. Both phacoemulsification and manual small incision extracapsular cataract surgery achieve excellent visual outcomes with low complication rates, but manual small incision extracapsular cataract surgery is significantly faster, less expensive and requires less technology. Therefore, manual small incision extracapsular cataract surgery may be the preferred technique for cataract surgery in the developing world.
The tenth annual survey of complications associated with foldable intraocular lenses (IOLs) requiring explantation or secondary intervention was sent to members of the American Society of Cataract and Refractive Surgery and the European Society of Cataract and Refractive Surgeons. Preoperative data about visual acuity, patient signs and symptoms, and complications requiring IOL removal were evaluated. Complications were then tabulated for each of the following major foldable IOL groups: 1-piece (plate) silicone, 1-piece hydrophobic acrylic with haptics, 3-piece silicone, 3-piece hydrophobic acrylic, 3-piece hydrophilic acrylic (hydrogel), 3-piece unknown, multifocal acrylic, and multifocal silicone. One hundred forty-two surveys were returned for evaluation. Dislocation/decentration, incorrect IOL power, glare/optical aberrations, and IOL calcification were the most common reasons for removing foldable IOLs. Good surgical technique, accurate IOL power measurements, and high manufacturing standards for foldable IOL materials and designs are the most important factors in preventing complications.
Although the total complication rates between the 2 groups were similar, the microkeratome group had significantly more epithelial defects intraoperatively and the femtosecond laser group had significantly more DLK cases postoperatively.
The donor graft underwent changes after DSEK, which may account for the induced hyperopia and its diminishment over time via changes in the posterior corneal curvature. Results suggest that intraocular lenses be targeted to -1.00 to -1.25 D of myopia for combined DSEK and cataract procedures.
Human ASCs on an HA-derived scaffold may be used as a source of keratocytes to regenerate extracellular matrix-like material in situations where the cornea stroma has been compromised.
Chemically modified and cross-linked derivative of hyaluronan improved corneal wound healing and could be useful for treating noninfectious corneal injuries.
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