Effect of PPV+ILM Peeling +/- Subretinal Injection of Ringer Lactate in Management of Nontractional Refractory DME

Launched by AIN SHAMS UNIVERSITY · Feb 14, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for patients with a condition called diabetic macular edema (DME) that is not responding well to standard therapies. The study will evaluate the effectiveness and safety of a procedure called pars plana vitrectomy, combined with a method to temporarily detach the fovea (the center of the retina) using a solution. This trial aims to help improve vision in patients who have had diabetes for over five years and who still have thickening of the central retina despite receiving regular injections for their condition.

To be eligible for this study, participants must be over 40 years old and have type 2 diabetes. They should also have certain levels of vision and central retina thickness that meet specific criteria. Importantly, candidates should not have other eye diseases that could affect the study results. If chosen to participate, individuals can expect to undergo the surgical procedure and will be closely monitored by doctors to assess how well the treatment works and whether it is safe. This trial is currently recruiting participants, so there is an opportunity to be part of a study that could lead to better management of diabetic macular edema.

Gender

ALL

Eligibility criteria

• 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 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:
• • 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