Clinical trial NCT05248139: Safety and Effectiveness of Drop-free Small Incision Cataract Surgery
Official title: Safety and Effectiveness of Single-dose Subconjunctival Triamcinolone Compared to Topical Prednisolone Eye Drops in Manual Small Incision Cataract Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract
Ocular Inflammation
Ocular Hypertension
Post-Op Complication
Lead sponsor: Visualiza
Sponsor class: OTHER
Collaborators: name: Seva Foundation
First posted: 2022-02-21
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean post-operative intraocular pressure (IOP) in mmHg in each group
timeFrame: Pre-operative exam through post-operative month week 12
measure: Corrected distance visual acuity (CDVA)
timeFrame: Pre-operative exam through post-operative week 12
Secondary outcomes:
measure: Degree of inflammation using anterior chamber (AC) inflammation score
timeFrame: Pre-operative exam through post-operative week 12
measure: Incidence of treatment-emergent macular edema
timeFrame: Post-operative month one through post-operative week 12
Other outcomes:
Locations:
Study officials:
affiliation: Seva Foundation
name: Neal Shorstein, MD
role: STUDY_CHAIR
References: