Safety and Effectiveness of Drop-free Small Incision Cataract Surgery

NCT05248139 | Unknown

• 1 other identifier: Dropfree MSICS
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Mean post-operative intraocular pressure (IOP) in mmHg in each group

  Comparison of mean IOP in mmHg obtained by applanation between control and intervention groups at all time points

  Pre-operative exam through post-operative month week 12

• Corrected distance visual acuity (CDVA)

  Comparison of visual acuity following refraction quantified on a the logarithm of the minimum angle of resolution (LogMAR) scale with a range from -0.30 (Snellen equivalent 6/3) with exceptional vision to +3.00 which corresponds to poor vision or only able to discriminate hand motions.

  Pre-operative exam through post-operative week 12

Secondary Outcomes (2)

• Degree of inflammation using anterior chamber (AC) inflammation score

  Pre-operative exam through post-operative week 12

• Incidence of treatment-emergent macular edema

  Post-operative month one through post-operative week 12

Study Arms (2)

Single-dose steroid medication delivered during surgery

EXPERIMENTAL

Subconjunctival injection of Triamcinolone acetonide.

Drug: Intraoperative delivery of medication, Kenalog (Triamcinolone)

Standard of care post-operative steroid drops

ACTIVE COMPARATOR

Prednisolone acetate ophthalmic solution, 4-week taper.

Drug: Topical post-operative eyedrops, Prednisolone acetate

Interventions

Intraoperative delivery of medication, Kenalog (Triamcinolone) 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.

Single-dose steroid medication delivered during surgery

Topical post-operative eyedrops, Prednisolone acetate 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.

Standard of care post-operative steroid drops

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Visualiza: lead
• Seva Foundation: collaborator

Related Publications (1)

• 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.

  PMID: 40630265 DERIVED

MeSH Terms

Conditions

Cataract; Ocular Hypertension; Postoperative Complications

Interventions

Triamcinolone Acetonide; Triamcinolone; prednisolone acetate

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Neal Shorstein, MD

  Seva Foundation

  STUDY CHAIR

Central Study Contacts

Lucia Silva, MD

CONTACT

50224140880; Lucia.Silva@visualiza.org.gt

Gena M Damento, MD

CONTACT

damento.gena@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: February 21, 2022
• Study Start: October 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: August 9, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share