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Outcomes of surgery with steroid implant given inside the eye for treatment of membrane formation over retina

Prospective study of vitrectomy with intravitreal dexamethasone implant for idiopathic epiretinal membrane

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/05/014336
Enrollment
33
Registered
2018-05-31
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Idiopathic Epiretinal Membrane

Interventions

Intervention1: Vitrectomy and membrane peeling and Intravitreal Dexamethasone Implant: Standard 25 G 3 port PPV done. After core vitrectomy, PVD is induced without staining with IVTA. Epiretinal membr

Sponsors

LV Prasad Eye Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a.Patients with idiopathic epiretinal membrane. b.Visual acuity 20/400 c.Central macular thickness > 300 µs as per OCT confirmed diagnosis d.Pseudophakic/ phakic patients e.Duration since diagnosis

Exclusion criteria

Exclusion criteria: a.Patient not willing to participate in the study b.Epiretinal membrane secondary to other retinal diseases like diabetic retinopathy, vascular occlusions, uveitis, age related macular degeneration, which can cause macular edema and decreased visual acuity. c.Aphakia, advanced glaucoma. d.Patients with hazy media. e.Advanced cataract or significant cataract that requires a cataract surgery within 1 year. f.Duration since diagnosis > 1 year. g.Epiretinal membrane with full thickness macular hole. h.Previous vitreoretinal surgery in the study eye or anticipated surgery within 12 months of enrolment. i.Previous pan retinal laser photocoagulation or macular laser photocoagulation in the study eye. j.Use of intraocular or periocular corticosteroids in the study eye previously. k.Previous treatment with anti-VEGF drugs in the study eye.

Design outcomes

Primary

MeasureTime frame
Change in log VA from baseline to 6 months post-operatively. Timepoint: 6 months

Secondary

MeasureTime frame
Proportions of subjects who gained 15 letters as per VA recorded at 6 months post-operatively, change from baseline CRT to 6 months post-operatively, difference between VA at 1 month and 6 months post-operatively, adverse drug effects like increased IOP, retinal detachment, cataract formation will be recorded.Timepoint: 6 months

Countries

India

Contacts

Public ContactDr Surabhi Sane

LV Prasad Eye Institute

narayanan@lvpei.org09177111975

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026