Safety and Effectiveness of Drop-free Small Incision Cataract Surgery

• Status: Not yet recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized control trial comparing the effects of subconjunctival triamcinolone administration during surgery to topical dexamethasone drops on the development of post-operative inflammation and macular edema in manual small incision cataract surgery.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Visualiza
• Collaborator: Seva Foundation
• Treatments: Ophthalmic Solutions

Criteria

Inclusion Criteria:

• Presence of a visually significant cataract: nuclear sclerotic, posterior subcapsular and/or cortical

• ASA class I-III

Exclusion Criteria:

• Axial length < 20 or > 26 mm

• Cataract which is traumatic, subluxated, or Morgagnian

• Presence of ocular comorbidity: including corneal or retinal abnormalities (corneal opacities, macular degeneration, macular scars, epiretinal membrane, retinal detachment, retinal vascular occlusion), glaucoma, ocular hypertension, glaucoma suspect (cup-to-disc ratio of 0.7 or more, history of steroid response, history of uveitis, pseudoexfoliation

• History of endophthalmitis or macular edema in the fellow eye

• Personal history of diabetes mellitus or uncontrolled hypertension

• Currently pregnant or lactating women

• Current use of systemic steroids for asthma, rheumatoid arthritis or other illness or history of steroid use by any route in the prior 3 months.

• Intraoperative complications including posterior capsular rupture, iris prolapse, zonular dialysis, retained nucleus, vitreous loss, iris trauma resulting in hemorrhage, Descemet dehiscence of more than 1 mm x 1 mm