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Safety and Effectiveness of Drop-free Small Incision Cataract Surgery

NCT05248139 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-08-09

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Seva Foundation

    collaborator OTHER

  • Visualiza

    lead OTHER

Principal Investigators

  • Neal Shorstein, MD · Seva Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-31
Primary Completion
2023-02-28
Completion
2023-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05248139 on ClinicalTrials.gov