Effect of PPV+ILM Peeling +/- Subretinal Injection of Ringer Lactate in Management of Nontractional Refractory DME
NCT ID: NCT06271473
Last Updated: 2024-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2023-08-30
2025-06-30
Brief Summary
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Detailed Description
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To evaluate the efficacy and safety of combined pars plana vitrectomy and planned foveal detachment through subretinal injection of ringer's solution in patients with non-tractional refractory diabetic macular edema.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* Group (A): 10 eyes subjecting to vitrectomy + ILM peeling only
* Group (B): 10 eyes subjecting to vitrectomy + ILM peeling + planned foveal detachment via subretinal injection of ringer's solution.
TREATMENT
NONE
Study Groups
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subjecting to vitrectomy + ILM peeling only
vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution.
vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution.
subjecting to vitrectomy + ILM peeling + planned foveal detachment
vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution.
vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution.
Interventions
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vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution.
vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution.
Eligibility Criteria
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Inclusion Criteria
* Patients with type two diabetes mellitus of more than 5 years duration.
* Patients with Best corrected visual acuity better than 3/60.
* Central macular thickness (CMT) of more than 250 μm despite undergoing six monthly injection of anti-VEGF therapy or corticosteroid or less than 10% reduction in CMT at the last follow up visit.
* No evidence of vitreomacular traction.
* Lens status: Pseudophakia or clear crystalline lens.
Exclusion Criteria
* Ischemic maculopathy by FFA.
* Presence of bad prognostic signs in OCT such as disorganization of inner retinal layers (DRIL) and extensive disruption of IS-OS junction subfoveally.
* Presence of apparent retinal pigment epithelium (RPE) atrophy at or near the macula.
* Presence of proliferative diabetic fibrovascular membranes threatening or at the macula.
* Presence of diabetic optic atrophy or neuropathy.
* Presence of neovascular glaucoma.
* Cataractous lens either preoperatively or as intra or postoperative complication.
* Vitrectomized Eyes.
* A prior intraocular surgery within the past six-months.
* Lost follow up
40 Years
80 Years
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Principal Investigators
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Abdelrahman G Salman, MD
Role: PRINCIPAL_INVESTIGATOR
professor at Ain Shams university
Locations
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Ain Shams university
Cairo, , Egypt
Ain Shams university
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AinShamsU3
Identifier Type: -
Identifier Source: org_study_id
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