NCT05248139

Safety and Effectiveness of Drop-free Small Incision Cataract Surgery

Safety and Effectiveness of Single-dose Subconjunctival Triamcinolone Compared to Topical Prednisolone Eye Drops in Manual Small Incision Cataract Surgery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Visualiza · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Eye drops given following cataract surgery for prevention of post-operative inflammation carry many disadvantages, such as cost and poor medication adherence. To eliminate these barriers, the emerging technique of single dose of subconjunctival triamcinolone delivered during surgery has been shown an effective and safe alternative. The goal of this study is to build on this evidence, utilizing subconjunctival triamcinolone in conjunction with a different surgical technique and population as what was previously studied. This is a randomized control trial comparing the effects of single-dose subconjunctival triamcinolone administration at the time of surgery to the standard 4-week taper of topical prednisolone drops following manual small incision cataract surgery in Guatemala. Patients will be evaluated at post-operative weeks 6 and 12 with the primary outcome variables of intraocular pressure and best corrected visual acuity. Data on presence and amount of corneal edema, anterior chamber inflammation, and development of macular edema will also be obtained.

Conditions

• Cataract
• Ocular Inflammation
• Ocular Hypertension
• Post-Op Complication

Interventions

Type	Name	Description
DRUG	Intraoperative delivery of medication, Kenalog (Triamcinolone)	Subconjunctival triamcinolone acetonide 4 mg (0.4 mL of 10 mg/mL solution), single-dose injected 6-8 mm inferior to the inferior limbus with a bent 27-gauge needle at completion of cataract surgery.
DRUG	Topical post-operative eyedrops, Prednisolone acetate	Standard of care Presnisolone acetate 1% ophthalmic drop taper: 4 times per day for first week, then tapering one drop per week for 3 additional weeks. Discontinued after 4 weeks.

Timeline

• Start date: 2022-10-01
• Primary completion: 2023-02-01
• Completion: 2023-02-01
• First posted: 2022-02-21
• Last updated: 2022-08-09