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

Last updated: August 3, 2024
Sponsor: Ain Shams University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Macular Edema

Treatment

vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution.

Clinical Study ID

NCT06271473
AinShamsU3
  • Ages 40-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 sixmonthly 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

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 retinallayers (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 themacula.

  • 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

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution.
Phase:
Study Start date:
August 30, 2023
Estimated Completion Date:
June 30, 2025

Study Description

In non-tractional cases, PPV allows a more efficient clearance of VEGF and other cytokines from the retina and improves retinal oxygenation by promotion of intraocular fluid currents, and relief of any subclinical tractional forces, thereby reducing DME.

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.

Connect with a study center

  • Ain Shams university

    Cairo,
    Egypt

    Active - Recruiting

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