Safety and Effectiveness of Drop-free Small Incision Cataract Surgery

Visualiza

Status: Not yet enrolling

Conditions: Post-Op Complication; Cataract; Ocular Hypertension; Ocular Inflammation

Treatments: Drug: Topical post-operative eyedrops, Prednisolone acetate; Drug: Intraoperative delivery of medication, Kenalog (Triamcinolone)

Study type: Interventional

Funder types: Other

Identifiers

NCT05248139

Dropfree MSICS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Single-dose steroid medication delivered during surgery

Experimental group

Description:

Subconjunctival injection of Triamcinolone acetonide.

Treatment:

Drug: Intraoperative delivery of medication, Kenalog (Triamcinolone)

Standard of care post-operative steroid drops

Active Comparator group

Description:

Prednisolone acetate ophthalmic solution, 4-week taper.

Treatment:

Drug: Topical post-operative eyedrops, Prednisolone acetate