Safety and Effectiveness of Drop-free Small Incision Cataract Surgery

NCT ID: NCT05248139

Last Updated: 2022-08-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-31
• Study Completion Date: 2023-02-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Single-dose steroid medication delivered during surgery

Subconjunctival injection of Triamcinolone acetonide.

Group Type: EXPERIMENTAL

Intraoperative delivery of medication, Kenalog (Triamcinolone)

Intervention Type: DRUG

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.

Standard of care post-operative steroid drops

Prednisolone acetate ophthalmic solution, 4-week taper.

Group Type: ACTIVE_COMPARATOR

Topical post-operative eyedrops, Prednisolone acetate

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seva Foundation

OTHER

Sponsor Role: collaborator

Visualiza

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neal Shorstein, MD

Role: STUDY_CHAIR

Seva Foundation

Central Contacts

Lucia Silva, MD

Role: CONTACT

Lucia.Silva@visualiza.org.gt

50224140880

Gena M Damento, MD

Role: CONTACT

damento.gena@gmail.com

References

Papa-Vettorazzi R, Shorstein NH, Peterson B, Yee Melgar M, Silva Linares L, O'Brien KS. Comparison of Subconjunctival Triamcinolone with Topical Prednisolone for Routine Anti-Inflammatory Prophylaxis in Manual Small Incision Cataract Surgery: A Single-Center, Randomized Controlled Trial Pilot Protocol. Clin Ophthalmol. 2025 Jul 4;19:2091-2105. doi: 10.2147/OPTH.S527039. eCollection 2025.

Reference Type: DERIVED

PMID: 40630265 (View on PubMed)

Other Identifiers

Dropfree MSICS

Identifier Type: -

Identifier Source: org_study_id