Clinical trial NCT06271473: Effect of PPV+ILM Peeling +/- Subretinal Injection of Ringer Lactate in Management of Nontractional Refractory DME
Official title: Comparative Study Between Pars Plana Vitrectomy With Internal Limiting Membrane Peeling With or Without Planned Foveal Detachment for Management of Non-tractional Refractory Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Efficacy
Safety
Keywords: refractory diabetic macular edema
internal limiting membrane peeling
pars plana vitrectomy
subretinal injection of ringer lactate
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 20 eyes of 20 patients will be divided randomly into 2 groups:

* 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.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: change in CMT by OCT at final visit
timeFrame: after 1 month and 3 months
Secondary outcomes:
measure: change in BCVA at final visit
timeFrame: after 1 month and 3 months
Other outcomes:
measure: any surgical complication or recurrence of DME
timeFrame: after 1 month and 3 months
Locations:
city: Cairo
country: Egypt
facility: Ain Shams university
city: Cairo
country: Egypt
facility: Ain Shams university
Study officials:
affiliation: professor at Ain Shams university
name: Abdelrahman G Salman, MD
role: PRINCIPAL_INVESTIGATOR
References: