Internal Limiting Membrane Peeling in Retinal Detachment Surgery

Retinal Detachment Clinical Trial

— IMPURITY  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05538156
• Other study ID #: 2022-A00665-38
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2022
• Est. completion date: December 2027

Study information

• Verified date: July 2022
• Source: Central Hospital, Nancy, France
• Contact: Jean-Baptiste CONART, Prof
• Phone: +33383155101
• Email: jbconart[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 126
• Est. completion date: December 2027
• Est. primary completion date: September 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Dissociative Disorders
• Proliferative Vitreoretinopathy
• Retinal Detachment

Intervention

Procedure:
• Control group
Vitrectomy and gas tamponade without internal limiting membrane peeling
• Intervention group
Vitrectomy, internal limiting membrane peeling and gas tamponade

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

References & Publications (6)

Borowicz D, Nowomiejska K, Nowakowska D, Brzozowska A, Toro MD, Avitabile T, Jünemann AG, Rejdak R. Functional and morphological results of treatment of macula-on and macula-off rhegmatogenous retinal detachment with pars plana vitrectomy and sulfur hexaf — View Citation

Charteris DG. Proliferative vitreoretinopathy: pathobiology, surgical management, and adjunctive treatment. Br J Ophthalmol. 1995 Oct;79(10):953-60. Review. — View Citation

Eissa MGAM, Abdelhakim MASE, Macky TA, Khafagy MM, Mortada HA. Functional and structural outcomes of ILM peeling in uncomplicated macula-off RRD using microperimetry & en-face OCT. Graefes Arch Clin Exp Ophthalmol. 2018 Feb;256(2):249-257. doi: 10.1007/s0 — View Citation

Fallico M, Russo A, Longo A, Pulvirenti A, Avitabile T, Bonfiglio V, Castellino N, Cennamo G, Reibaldi M. Internal limiting membrane peeling versus no peeling during primary vitrectomy for rhegmatogenous retinal detachment: A systematic review and meta-an — View Citation

Foveau P, Leroy B, Berrod JP, Conart JB. Internal Limiting Membrane Peeling in Macula-off Retinal Detachment Complicated by Grade B Proliferative Vitreoretinopathy. Am J Ophthalmol. 2018 Jul;191:1-6. doi: 10.1016/j.ajo.2018.03.037. Epub 2018 Apr 3. — View Citation

Steel DH, Joussen AM, Wong D. ILM peeling in rhegmatogenous retinal detachment; does it improve the outcome? Graefes Arch Clin Exp Ophthalmol. 2018 Feb;256(2):247-248. doi: 10.1007/s00417-017-3876-6. Epub 2017 Dec 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary anatomical success rate	Primary retinal reattachment rate	12 months after surgery
Secondary	Functional outcomes #1	Visual acuity (Logarithm of the Minimum Angle of Resolution)	12 months after surgery
Secondary	Functional outcomes #2	Degree of metamorphopsia (M-CHARTS)	12 months after surgery
Secondary	Anatomical outcomes #1	Integrity of the photoreceptor layer on Spectral Domain Optical Coherence Tomography	12 months after surgery
Secondary	Anatomical outcomes #2	Incidence of epiretinal membrane	12 months after surgery
Secondary	Anatomical outcomes #3	Incidence of cystoid macular edema	12 months after surgery
Secondary	Anatomical outcomes #4	Incidence of DONFL appearance	12 months after surgery
Secondary	Functional outcomes #3	Retinal sensitivity on microperimetry testing	12 months after surgery