Impact of ILM Peeling in RRD/ I-Peel

Retinal Detachment Clinical Trial

— I-Peel  

Official title:

Impact of ILM Peeling on Functional and Anatomic Outcomes of Vitrectomy for Primary Rhegmatogenous Retinal Detachment - the I-Peel Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04767555
• Other study ID #: I-Peel 2021-00027
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 23, 2022
• Est. completion date: June 2026

Study information

• Verified date: April 2024
• Source: Berner Augenklinik
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 250
• Est. completion date: June 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Retinal Detachment

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Switzerland	Berner Augenklinik	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Berner Augenklinik

Country where clinical trial is conducted

Switzerland, 

References & Publications (7)

Aras C, Arici C, Akar S, Muftuoglu G, Yolar M, Arvas S, Baserer T, Koyluoglu N. Peeling of internal limiting membrane during vitrectomy for complicated retinal detachment prevents epimacular membrane formation. Graefes Arch Clin Exp Ophthalmol. 2009 May;247(5):619-23. doi: 10.1007/s00417-008-1025-y. Epub 2008 Dec 24. — View Citation

Garweg JG, Bergstein D, Windisch B, Koerner F, Halberstadt M. Recovery of visual field and acuity after removal of epiretinal and inner limiting membranes. Br J Ophthalmol. 2008 Feb;92(2):220-4. doi: 10.1136/bjo.2007.131862. Epub 2007 Nov 30. — View Citation

Garweg JG, Deiss M, Pfister IB, Gerhardt C. IMPACT OF INNER LIMITING MEMBRANE PEELING ON VISUAL RECOVERY AFTER VITRECTOMY FOR PRIMARY RHEGMATOGENOUS RETINAL DETACHMENT INVOLVING THE FOVEA. Retina. 2019 May;39(5):853-859. doi: 10.1097/IAE.0000000000002046. — View Citation

Hohn F, Kretz FT, Pavlidis M. [Primary vitrectomy with peeling of the internal limiting membrane under decaline: a promising surgical maneuver for treatment of total and subtotal retinal detachment]. Ophthalmologe. 2014 Sep;111(9):882-6. doi: 10.1007/s00347-014-3158-1. German. — View Citation

Kodjikian L, Richter T, Halberstadt M, Beby F, Flueckiger F, Boehnke M, Garweg JG. Toxic effects of indocyanine green, infracyanine green, and trypan blue on the human retinal pigmented epithelium. Graefes Arch Clin Exp Ophthalmol. 2005 Sep;243(9):917-25. doi: 10.1007/s00417-004-1121-6. Epub 2005 Apr 15. — View Citation

Koerner F, Garweg J. Advances in the management of vitreomacular traction syndrome and macular hole. Dev Ophthalmol. 1997;29:15-29. doi: 10.1159/000060723. No abstract available. — View Citation

Odrobina D, Bednarski M, Cisiecki S, Michalewska Z, Kuhn F, Nawrocki J. Internal limiting membrane peeling as prophylaxis of macular pucker formation in eyes undergoing retinectomy for severe proliferative vitreoretinopathy. Retina. 2012 Feb;32(2):226-31. doi: 10.1097/IAE.0b013e31821a12e9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients developing secondary epiretinal membrane formation	Clinically significant secondary epiretinal membrane formation requiring revision surgery	12 months
Secondary	Rate of re-detachments in patients	Revision surgery due to re-detachment independently of secondary epiretinal membrane formation	12 months
Secondary	Best-corrected visual acuity	Change in best-corrected visual acuity	12 months
Secondary	Complication rates	Intra- and postoperative complication rates including PVR	12 months
Secondary	Surgical times	How long does the surgery take	minutes (0-300)