Back to resultsSafety and Effectiveness of Drop-free Small Incision Cataract Surgery
Primary Purpose
Cataract, Ocular Inflammation, Ocular Hypertension
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intraoperative delivery of medication, Kenalog (Triamcinolone)
Topical post-operative eyedrops, Prednisolone acetate
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Single-dose steroid medication delivered during surgery
Standard of care post-operative steroid drops
Arm Description
Subconjunctival injection of Triamcinolone acetonide.
Prednisolone acetate ophthalmic solution, 4-week taper.
Outcomes
Primary Outcome Measures
Mean post-operative intraocular pressure (IOP) in mmHg in each group
Comparison of mean IOP in mmHg obtained by applanation between control and intervention groups at all time points
Corrected distance visual acuity (CDVA)
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
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
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.
Full Information
NCT ID
NCT05248139
First Posted
December 8, 2021
Last Updated
August 4, 2022
Sponsor
Visualiza
Collaborators
Seva Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05248139
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Visualiza
Collaborators
Seva Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Ocular Inflammation, Ocular Hypertension, Post-Op Complication
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single-dose steroid medication delivered during surgery
Arm Type
Experimental
Arm Description
Subconjunctival injection of Triamcinolone acetonide.
Arm Title
Standard of care post-operative steroid drops
Arm Type
Active Comparator
Arm Description
Prednisolone acetate ophthalmic solution, 4-week taper.
Intervention Type
Drug
Intervention Name(s)
Intraoperative delivery of medication, Kenalog (Triamcinolone)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Topical post-operative eyedrops, Prednisolone acetate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean post-operative intraocular pressure (IOP) in mmHg in each group
Description
Comparison of mean IOP in mmHg obtained by applanation between control and intervention groups at all time points
Time Frame
Pre-operative exam through post-operative month week 12
Title
Corrected distance visual acuity (CDVA)
Description
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.
Time Frame
Pre-operative exam through post-operative week 12
Secondary Outcome Measure Information:
Title
Degree of inflammation using anterior chamber (AC) inflammation score
Description
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.
Time Frame
Pre-operative exam through post-operative week 12
Title
Incidence of treatment-emergent macular edema
Description
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.
Time Frame
Post-operative month one through post-operative week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucia Silva, MD
Phone
50224140880
Email
Lucia.Silva@visualiza.org.gt
First Name & Middle Initial & Last Name or Official Title & Degree
Gena M Damento, MD
Email
damento.gena@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal Shorstein, MD
Organizational Affiliation
Seva Foundation
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Effectiveness of Drop-free Small Incision Cataract Surgery
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