Effect of PPV+ILM Peeling +/- Subretinal Injection of Ringer Lactate in Management of Nontraction… (NCT06271473) | Clinical Trial Compass
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Effect of PPV+ILM Peeling +/- Subretinal Injection of Ringer Lactate in Management of Nontractional Refractory DME
Egypt20 participantsStarted 2023-08-30
Plain-language summary
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.
Who can participate
Age range40 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age: above 40 years old.
* 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 ÎĽm 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:
Other causes of macular edema (intraocular inflammation, retinal vein occlusion, Irvin-gass syndrome, pharmacological).
* 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