Impact of ILM Peeling in RRD/ I-Peel

Berner Augenklinik

Status

Active, not recruiting

Conditions

Retinal Detachment

Treatments

Procedure: ILM (inner limiting membrane) peeling

Study type

Interventional

Funder types

Other

Identifiers

NCT04767555

I-Peel 2021-00027

Details and patient eligibility

About

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.

Enrollment

250 estimated patients

Sex

All

Ages

18 to 110 years old

Volunteers

No Healthy Volunteers

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