Retinal Detachment
Conditions
Keywords
retinal detachment, ILM-peeling
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.
Interventions
PROCEDUREILM (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.
Sponsors
Berner Augenklinik
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients developing secondary epiretinal membrane formation | 12 months | Clinically significant secondary epiretinal membrane formation requiring revision surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of re-detachments in patients | 12 months | Revision surgery due to re-detachment independently of secondary epiretinal membrane formation |
| Best-corrected visual acuity | 12 months | Change in best-corrected visual acuity |
| Complication rates | 12 months | Intra- and postoperative complication rates including PVR |
| Surgical times | minutes (0-300) | How long does the surgery take |
Countries
Switzerland
Outcome results
None listed