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Safety and Effectiveness of Drop-free Small Incision Cataract Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05248139
Recruitment Status : Not yet recruiting
First Posted : February 21, 2022
Last Update Posted : August 9, 2022
Sponsor:
Collaborator:
Seva Foundation
Information provided by (Responsible Party):
Visualiza

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
Cataract Ocular Inflammation Ocular Hypertension Post-Op Complication Drug: Intraoperative delivery of medication, Kenalog (Triamcinolone) Drug: Topical post-operative eyedrops, Prednisolone acetate Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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


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.




Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Lucia Silva, MD 50224140880 Lucia.Silva@visualiza.org.gt
Contact: Gena M Damento, MD damento.gena@gmail.com

Sponsors and Collaborators
Visualiza
Seva Foundation
Investigators
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Study Chair: Neal Shorstein, MD Seva Foundation
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Responsible Party: Visualiza
ClinicalTrials.gov Identifier: NCT05248139    
Other Study ID Numbers: Dropfree MSICS
First Posted: February 21, 2022    Key Record Dates
Last Update Posted: August 9, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cataract
Ocular Hypertension
Inflammation
Postoperative Complications
Pathologic Processes
Lens Diseases
Eye Diseases
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Triamcinolone
Triamcinolone Acetonide
Ophthalmic Solutions
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents