Safety and Effectiveness of Drop-free Small Incision Cataract Surgery
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|ClinicalTrials.gov Identifier: NCT05248139|
Recruitment Status : Not yet recruiting
First Posted : February 21, 2022
Last Update Posted : August 9, 2022
|Condition or disease||Intervention/treatment||Phase|
|Cataract Ocular Inflammation Ocular Hypertension Post-Op Complication||Drug: Intraoperative delivery of medication, Kenalog (Triamcinolone) Drug: Topical post-operative eyedrops, Prednisolone acetate||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Safety and Effectiveness of Single-dose Subconjunctival Triamcinolone Compared to Topical Prednisolone Eye Drops in Manual Small Incision Cataract Surgery|
|Estimated Study Start Date :||October 2022|
|Estimated Primary Completion Date :||February 2023|
|Estimated Study Completion Date :||February 2023|
Experimental: Single-dose steroid medication delivered during surgery
Subconjunctival injection of Triamcinolone acetonide.
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.
Active Comparator: Standard of care post-operative steroid drops
Prednisolone acetate ophthalmic solution, 4-week taper.
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.
- Mean post-operative intraocular pressure (IOP) in mmHg in each group [ Time Frame: Pre-operative exam through post-operative month week 12 ]Comparison of mean IOP in mmHg obtained by applanation between control and intervention groups at all time points
- Corrected distance visual acuity (CDVA) [ Time Frame: Pre-operative exam through post-operative week 12 ]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.
- Degree of inflammation using anterior chamber (AC) inflammation score [ Time Frame: Pre-operative exam through post-operative week 12 ]Comparison between groups; score obtained by slit lamp examination by a single, non-operating investigational surgeon at all clinic time points. Patients will receive a number for anterior chamber cell ranging from 0 which equals no inflammatory cells visible to 4, or >50 visible cells in the anterior chamber according to the Standardization of Uveitis Nomenclature (SUN) scoring system. This will then be added to the patient's flare score ranging from 0, or no flare, to 4+, which signifies high levels of inflammation, such as fixed or plastic anterior chamber fluid. The summation of these values will determine the patient's overall anterior inflammation score for that examination date.
- Incidence of treatment-emergent macular edema [ Time Frame: Post-operative month one through post-operative week 12 ]Incidence of macular edema compared between treatment groups. Macular edema defined as BCVA of 20/40 or worse and ocular coherence tomography with identifiable cystoid spaces within the macula (central 1 mm) or central subfield thickening of 320 µm or greater.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05248139
|Contact: Lucia Silva, MD||50224140880||Lucia.Silva@visualiza.org.gt|
|Contact: Gena M Damento, MDemail@example.com|
|Study Chair:||Neal Shorstein, MD||Seva Foundation|