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

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.

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.

Inclusion Criteria:

• Presence of a visually significant cataract: nuclear sclerotic, posterior subcapsular and/or cortical
• Best corrected visual acuity or 20/40 or worse

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