Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT05538156

Internal Limiting Membrane Peeling in Retinal Detachment Surgery

Despite advances in surgical techniques over the recent decades, proliferative vitreoretinopathy (PVR) remains the main obstacle to successful rhegmatogenous retinal detachment (RRD) repair, accounting for nearly 75% of all primary surgical failures. It is characterized by the growth and contraction of cellular membranes within the vitreous cavity and on both surfaces of the detached retina as well as intraretinal fibrosis.

The Retina Society classification, modified in 1991 and currently the most widely used, divided PVR into three grades. Grade A is limited to the presence of vitreous haze and pigment clumps. Grade B includes rolled or irregular edges of tear and/or inner retinal surface wrinkling with possible retinal stiffness and vessel tortuosity. Grade C is defined as the presence of full-thickness fixed retinal folds and is further subdivided based on the number of hours involved and the location.

Recently, Foveau et al., in a retrospective comparative case series, have demonstrated that performing internal limiting membrane (ILM) peeling during RRD surgery may increase the anatomical success rate for this indication.

The aim of this multi-center, prospective, randomized controlled clinical trial study is to evaluate the effectiveness of ILM peeling on surgical outcomes in patients with primary macula-off RRD complicated by grade B PVR.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Despite advances in surgical techniques over the recent decades, proliferative vitreoretinopathy (PVR) remains the main obstacle to successful rhegmatogenous retinal detachment (RRD) repair, accounting for nearly 75% of all primary surgical failures. It is characterized by the growth and contraction of cellular membranes within the vitreous cavity and on both surfaces of the detached retina as well as intraretinal fibrosis.

The Retina Society classification, modified in 1991 and currently the most widely used, divided PVR into three grades. Grade A is limited to the presence of vitreous haze and pigment clumps. Grade B includes rolled or irregular edges of tear and/or inner retinal surface wrinkling with possible retinal stiffness and vessel tortuosity. Grade C is defined as the presence of full-thickness fixed retinal folds and is further subdivided based on the number of hours involved and the location.

Grade B PVR is thought to represent an immature form of PVR with a definite potential for progression to further stages of PVR. Specific treatment for moderate PVR seems to be essential to halt the disease process and to reduce the risk of postoperative re-detachment. However, there is currently no consensus regarding the management of grade PVR. In macula-off RRD, vitrectomy with gas tamponade is often used as a primary option, with a retinal reattachment rate of 60%.

Recently, Foveau et al., in a retrospective comparative case series, have demonstrated that performing internal limiting membrane (ILM) peeling during RRD surgery may increase the anatomical success rate for this indication.

The aim of this multi-center, prospective, randomized controlled clinical trial study is to evaluate the effectiveness of ILM peeling on surgical outcomes in patients with primary macula-off RRD complicated by grade B PVR.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients older than 18 years old
  • With macula-off retinal detachment complicated by grade B proliferative vitreoretinopathy

Exclusion criteria

  • Underage patients
  • History of retinal detachment
  • History of intraocular surgery (except for cataract surgery)
  • Traumatic retinal detachment
  • Macular hole-associated retinal detachment
  • Concurrent macular disease (diabetic maculopathy, age-related macular degeneration)

Treatment and study plan

Control Group

Procedure

Vitrectomy and gas tamponade without internal limiting membrane peeling

Intervention group

Procedure

Vitrectomy, internal limiting membrane peeling and gas tamponade

Primary outcomes

  1. Primary anatomical success rate

    Time frame: 12 months after surgery

    Primary retinal reattachment rate

Secondary outcomes

  1. Functional outcomes #1

    Time frame: 12 months after surgery

    Visual acuity (Logarithm of the Minimum Angle of Resolution)

  2. Functional outcomes #2

    Time frame: 12 months after surgery

    Degree of metamorphopsia (M-CHARTS)

  3. Anatomical outcomes #1

    Time frame: 12 months after surgery

    Integrity of the photoreceptor layer on Spectral Domain Optical Coherence Tomography

  4. Anatomical outcomes #2

    Time frame: 12 months after surgery

    Incidence of epiretinal membrane

  5. Anatomical outcomes #3

    Time frame: 12 months after surgery

    Incidence of cystoid macular edema

  6. Anatomical outcomes #4

    Time frame: 12 months after surgery

    Incidence of DONFL appearance

  7. Functional outcomes #3

    Time frame: 12 months after surgery

    Retinal sensitivity on microperimetry testing

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Baptiste CONART, Prof

CONTACT

[email protected]

+33383155101

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Internal Limiting Membrane Peeling in Macula-off Retinal Detachment With Grade B Proliferative Vitreoretinopathy

Acronym: IMPURITY

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Sep 13, 2022
Registry last updated
Sep 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.