Impact of ILM Peeling in RRD/ I-Peel

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-23

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Retinal detachment is associated with a substantial risk of re-detachment in 10-20% and to the formation of secondary epiretinal membranes in up to 15%. Relevant postoperative vision loss is encountered in many instances, primarily in consequence of macular involvement, but also secondarily due to postoperative complications, namely the formation of an epiretinal membrane and proliferative vitreoretinopathy. These mechanical reasons of influence can potentially be prevented by ILM peeling during reattachment surgery. This, however, is not a generally accepted standard of care during primary routine vitrectomy.

Two groups suffering from primary retinal detachment will be compared: the first group will receive standard re-attachment vitrectomy surgery, whereas the second group will receive an identical vitrectomy surgery, but with additional ILM peeling. In this study, the investigators wish to assess the influence of ILM peeling on visual outcomes and postoperative complications over 12 months.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Internal Limiting Membrane Peeling in Proliferative Diabetic Retinopathy

NCT04380064

Diabetic Retinopathy Visually Threatening

ACTIVE_NOT_RECRUITING NA

Evaluation of Vitrectomy With ILM Peeling in Myopic Macular Hole With Only Posterior Retinal Detachment

NCT06194760

Retinal Detachment

ACTIVE_NOT_RECRUITING NA

Observational Study - ILM Peeling

NCT01083056

Epimacular Gliosis Macular Hole

COMPLETED

Effects of Internal Limiting Membrane Peeling on Visual Function in Epiretinal Membrane Surgery

NCT04130841

Retinal Disease Epiretinal Membrane

UNKNOWN NA

Outcomes of Extensive Brilliant Blue G-Assisted Internal Limiting Membrane Peeling in Proliferative Vitreoretinopathy

NCT04490876

Proliferative Vitreoretinopathy

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Retinal Detachment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ILM (inner limiting membrane) peeling

ILM peeling adding to standard vitreous surgery in patients suffering from retinal detachment

Group Type EXPERIMENTAL

ILM (inner limiting membrane) peeling

Intervention Type PROCEDURE

The standard technique for the removal of the inner limiting membrane is a dye-assisted ILM peeling established since 20 years as the standard of care to treat vision loss due to epiretinal membranes or macular holes in eyes with an otherwise stable retina, but not during retinal detachment surgery. Other dyes may show a stronger staining effect but since there is evidence of a potential toxicity of ICG the investigators use the well-tolerated and for this purpose approved trypan blue dye Membrane Blue ® (Dorc). This intervention will be performed in addition to standard vitreoretinal re-attachment surgery.

No Peeling

standard vitreous surgery without ILM peeling in patients suffering from retinal detachment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ILM (inner limiting membrane) peeling

The standard technique for the removal of the inner limiting membrane is a dye-assisted ILM peeling established since 20 years as the standard of care to treat vision loss due to epiretinal membranes or macular holes in eyes with an otherwise stable retina, but not during retinal detachment surgery. Other dyes may show a stronger staining effect but since there is evidence of a potential toxicity of ICG the investigators use the well-tolerated and for this purpose approved trypan blue dye Membrane Blue ® (Dorc). This intervention will be performed in addition to standard vitreoretinal re-attachment surgery.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* primary rhegmatogenous retinal detachment
* of legal age (18 years or older)
* in case of bilateral retinal detachment, only the first-affected eye will be included

Exclusion Criteria

* pre-existing functional and morphological changes to the macula, hindering visual recovery (amblyopia, trauma, macular degeneration)
* advanced retinal detachment with PVR stage C2 or more
* eyes pre-operated within six months prior to the development of RD
* state after any vitreoretinal surgery
* state after complicated cataract surgery, including aphakia and anterior chamber lens implantation
* patients with increased risk profiles
* myopia magna (≥7 diopters)
* advanced diabetic retinopathy
* any chronic ocular or systemic inflammatory disease
* any other proliferative systemic disease or condition associated with impaired wound healing

Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No