Safety and Effectiveness of Drop-free Small Incision Cataract Surgery (NCT05248139) | Clinical Trial Compass
UnknownNot Applicable
Safety and Effectiveness of Drop-free Small Incision Cataract Surgery
100 participantsStarted 2022-10
Plain-language 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.
Who can participate
Age range50 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Mean post-operative intraocular pressure (IOP) in mmHg in each group
Timeframe: Pre-operative exam through post-operative month week 12
2
Corrected distance visual acuity (CDVA)
Timeframe: Pre-operative exam through post-operative week 12