Safety and Effectiveness of Drop-free Small Incision Cataract Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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.
|
Outcome Measures
Primary Outcome Measures
- Mean post-operative intraocular pressure (IOP) in mmHg in each group [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) [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.
Secondary Outcome Measures
- Degree of inflammation using anterior chamber (AC) inflammation score [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 [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Presence of a visually significant cataract: nuclear sclerotic, posterior subcapsular and/or cortical
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Best corrected visual acuity or 20/40 or worse
Exclusion Criteria:
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Axial length < 20 or > 26 mm
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Cataract which is traumatic, subluxated, or Morgagnian
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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
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History of endophthalmitis or macular edema in the fellow eye
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Personal history of diabetes mellitus or uncontrolled hypertension
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Currently pregnant or lactating women
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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.
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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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Visualiza
- Seva Foundation
Investigators
- Study Chair: Neal Shorstein, MD, Seva Foundation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Dropfree MSICS