Novel Cross-Linked Ocular Bandage Gel Improves Reepithelialization After Photorefractive Keratectomy: A Randomized, Masked Prospective Study
Autor: | Lisa A Brandano, Darcy Wolsey, Daniel S. Durrie, Stephen G. Slade, Barbara M Wirostko, Vance Thompson, Brenda K. Mann |
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Rok vydání: | 2020 |
Předmět: |
Adult
Male Intraocular pressure medicine.medical_specialty genetic structures Contact Lenses medicine.medical_treatment Visual Acuity Fundus (eye) Photorefractive Keratectomy Lubricant Eye Drops Cornea Adjuvants Immunologic Re-Epithelialization Ophthalmology Myopia Humans Medicine Pharmacology (medical) Prospective Studies Hyaluronic Acid Anisometropia Postoperative Care Pharmacology Wound Healing Slit Lamp Slit lamp business.industry Middle Aged medicine.disease Bandages eye diseases Photorefractive keratectomy Artificial tears Treatment Outcome medicine.anatomical_structure Case-Control Studies Female Fluorescein sense organs Safety business Bandage |
Zdroj: | Journal of Ocular Pharmacology and Therapeutics. 36:602-608 |
ISSN: | 1557-7732 1080-7683 |
Popis: | Purpose: To compare, in a masked manner, a novel cross-linked hyaluronic acid ocular bandage gel (OBG) versus standard-of-care bandage contact lens (BCL) plus artificial tears with respect to safety and effectiveness in healing epithelial defects created for photorefractive keratectomy (PRK). Methods: This was a randomized, reading center-masked, exploratory study. Forty-five patients (myopic without significant anisometropia) scheduled for bilateral PRK (9-mm epithelial defect) were randomized post-PRK to treatment with OBG 8 times daily for 3 days, followed by 4 times daily for 11 days (Group 1); OBG 4 times daily for 14 days (Group 2); or BCL and artificial tears (Control). A masked reading center used image analysis of digital slit lamp photos of the fluorescein-stained cornea to evaluate defect size during the 14-day postoperative follow-up period. Effectiveness endpoints were (1) time to complete closure of the corneal defect and (2) proportion of patients with complete healing on day 3 postoperatively, whose defect remained closed. Safety assessments included findings for adverse events and vision, Standard Patient Evaluation of Eye Dryness (SPEED™) Questionnaire, slit lamp, intraocular pressure, and fundus examinations. Results: The proportion of patients with complete healing at 3 days was 73.3%, 86.7%, and 66.7% of patients in Groups 1, 2, and Control, respectively. On day 2, the mean wound size was 6%-26% smaller in Groups 1 and 2 compared with Control. No safety concern arose. SPEED scores were not significantly different across groups. Conclusion: OBG offers a well-tolerated and effective therapy for quickly reepithelializing the cornea following trauma, disease, or surgery. |
Databáze: | OpenAIRE |
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