Clinical trial NCT04767555: Impact of ILM Peeling in RRD/ I-Peel
Official title: Impact of ILM Peeling on Functional and Anatomic Outcomes of Vitrectomy for Primary Rhegmatogenous Retinal Detachment - the I-Peel Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Retinal Detachment
Keywords: retinal detachment
ILM-peeling
Lead sponsor: Berner Augenklinik
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients developing secondary epiretinal membrane formation
timeFrame: 12 months
Secondary outcomes:
measure: Rate of re-detachments in patients
timeFrame: 12 months
measure: Best-corrected visual acuity
timeFrame: 12 months
measure: Complication rates
timeFrame: 12 months
measure: Surgical times
timeFrame: minutes (0-300)
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Berner Augenklinik
Study officials:
affiliation: Berner Augenklinik
name: Justus G Garweg, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.
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.
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.