Status:
UNKNOWN
Safety and Effectiveness of Drop-free Small Incision Cataract Surgery
Lead Sponsor:
Visualiza
Collaborating Sponsors:
Seva Foundation
Conditions:
Cataract
Ocular Inflammation
Eligibility:
All Genders
50-75 years
Phase:
NA
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 ...
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...
Eligibility Criteria
Inclusion
- Presence of a visually significant cataract: nuclear sclerotic, posterior subcapsular and/or cortical
- Best corrected visual acuity or 20/40 or worse
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05248139
Start Date
October 1 2022
End Date
February 1 2023
Last Update
August 9 2022
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.