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Internal Limiting Membrane Peeling in Retinal Detachment Surgery

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05538156
Acronym
IMPURITY
Enrollment
126
Registered
2022-09-13
Start date
2022-09-30
Completion date
2027-12-31
Last updated
2022-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proliferative Vitreoretinopathy, Retinal Detachment

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREControl group

Vitrectomy and gas tamponade without internal limiting membrane peeling

PROCEDUREIntervention group

Vitrectomy, internal limiting membrane peeling and gas tamponade

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Primary anatomical success rate12 months after surgeryPrimary retinal reattachment rate

Secondary

MeasureTime frameDescription
Functional outcomes #212 months after surgeryDegree of metamorphopsia (M-CHARTS)
Anatomical outcomes #112 months after surgeryIntegrity of the photoreceptor layer on Spectral Domain Optical Coherence Tomography
Anatomical outcomes #212 months after surgeryIncidence of epiretinal membrane
Functional outcomes #112 months after surgeryVisual acuity (Logarithm of the Minimum Angle of Resolution)
Anatomical outcomes #412 months after surgeryIncidence of DONFL appearance
Functional outcomes #312 months after surgeryRetinal sensitivity on microperimetry testing
Anatomical outcomes #312 months after surgeryIncidence of cystoid macular edema

Contacts

Primary ContactJean-Baptiste CONART, Prof
jbconart@hotmail.com+33383155101

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026