Retinal DetachmentNCT07438210
Peeling of the Internal Limiting Membrane During Primary Vitrectomy for Retinal Detachment Repair
A study testing ILM-Peeling and No Peeling in people with Retinal Detachment, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial summary
Primary vitrectomy for retinal detachment repair is one of the current methods for surgical treatment of retinal detachment. Additional peeling of the internal limiting membrane (ILM) was reported to successfully prevent development of epiretinal membranes after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Detachment
- What is being tested?
- ILM-Peeling and No Peeling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteAustria
- Study dates
- 3 Apr 2019to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- retinal detachment
- age: 18 or older
- written informed consent for surgery and participation in the study prior to surgery
Who cannot join
- pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Peeling of the Internal Limiting Membrane on Vision Results After Primary Vitrectomy for Retinal Detachment Repair
Primary vitrectomy for retinal detachment repair is one of the current methods for surgical treatment of retinal detachment. Additional peeling of the internal limiting membrane (ILM) was reported to successfully prevent development of epiretinal membranes after surgery. The aim of the study is to examine the effect of ILM-Peeling on visual acuity outcomes and on occurrence of postoperative epiretinal membranes.
Read the detailed description
Retinal detachment is a disorder, usually caused by peripheral retinal breaks, that leads to severe decrease in vision in untreated cases. Primary vitrectomy for retinal detachment repair is one of the current methods for surgical treatment of retinal detachment. Recent retrospective studies support the hypothesis, that peeling of the internal limiting membrane (ILM) is beneficial on postoperative visual acuity and lower rates of occurrence of epiretinal membranes after surgery [Forlini et al. 2018].
The aim of the study is to examine the effect of ILM-Peeling on visual acuity outcomes and on occurrence of postoperative epiretinal membranes.
- Conditions
- Retinal Detachment
- Being tested
- ILM-Peeling, No Peeling
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ILM-PeelingProcedure or surgery
during primary vitrectomy for retinal detachment repair additional ILM-Peeling is performed
No PeelingProcedure or surgery
during primary vitrectomy for retinal detachment repair no additional ILM-Peeling is performed
| Study group | Role | What they receive |
|---|---|---|
| ILM-Peeling | Experimental | Not described Receives: Procedure: ILM-Peeling |
| No Peeling | Active comparator | Not described Receives: Procedure: No Peeling |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity
Measured: from enrollment to the end of follow-up at 4 years after surgery
Secondary outcomes (1)
occurrence of epiretinal membranes
Measured: from enrollment to the follow-up at 4 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start3 Apr 2019
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Why it stopped: Peeling of the internal limiting membrane has shown risks to leave full thickness retinal defects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinal DetachmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vienna Institute for Research in Ocular Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438210
- Sponsor's protocol ID
- RD_ILM
- Status last verified
- Feb 2026
- First submitted
- 22 Feb 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Forlini M, Date P, Ferrari LM, Lorusso M, Lecce G, Verdina T, Neri G, Benatti C, Rossini P, Bratu A, D'Eliseo D, Ferrari TM, Cavallini GM. COMPARATIVE ANALYSIS OF RETINAL REATTACHMENT SURGERY WITH OR WITHOUT INTERNAL LIMITING MEMBRANE PEELING TO PREVENT POSTOPERATIVE MACULAR PUCKER. Retina. 2018 Sep;38(9):1770-1776. doi: 10.1097/IAE.0000000000001775.
PubMed 28723849
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Peeling of the Internal Limiting Membrane on Vision Results After Primary Vitrectomy for Retinal Detachment Repair
- ClinicalTrials.gov ID
- NCT07438210
- Acronym / sponsor ID
- RD_ILM
- Conditions
- Retinal Detachment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Peeling of the internal limiting membrane has shown risks to leave full thickness retinal defects
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary vitrectomy for retinal detachment repair is one of the current methods for surgical treatment of retinal detachment. Additional peeling of the internal limiting membrane (ILM) was reported to successfully prevent development of epiretinal membranes after surgery. The aim of the study is to examine the effect of ILM-Peeling on visual acuity outcomes and on occurrence of postoperative epiretinal membranes.
Detailed description
Retinal detachment is a disorder, usually caused by peripheral retinal breaks, that leads to severe decrease in vision in untreated cases. Primary vitrectomy for retinal detachment repair is one of the current methods for surgical treatment of retinal detachment. Recent retrospective studies support the hypothesis, that peeling of the internal limiting membrane (ILM) is beneficial on postoperative visual acuity and lower rates of occurrence of epiretinal membranes after surgery [Forlini et al. 2018].
The aim of the study is to examine the effect of ILM-Peeling on visual acuity outcomes and on occurrence of postoperative epiretinal membranes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ILM-Peeling | Experimental | Procedure: ILM-Peeling |
| No Peeling | Active comparator | Procedure: No Peeling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- retinal detachment
- age: 18 or older
- written informed consent for surgery and participation in the study prior to surgery
Key exclusion criteria (1 listed)
- pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ILM-Peelingduring primary vitrectomy for retinal detachment repair additional ILM-Peeling is performed | Procedure or surgery | ILM-Peeling |
| No Peelingduring primary vitrectomy for retinal detachment repair no additional ILM-Peeling is performed | Procedure or surgery | No Peeling |
Primary outcome
visual acuity
Time frame: from enrollment to the end of follow-up at 4 years after surgery
1 secondary outcome
occurrence of epiretinal membranes
Time frame: from enrollment to the follow-up at 4 years after surgery
Results and safety
The study was stopped early (reason given: Peeling of the internal limiting membrane has shown risks to leave full thickness retinal defects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Background: PubMed 28723849Forlini M, Date P, Ferrari LM, Lorusso M, Lecce G, Verdina T, Neri G, Benatti C, Rossini P, Bratu A, D'Eliseo D, Ferrari TM, Cavallini GM. COMPARATIVE ANALYSIS OF RETINAL REATTACHMENT SURGERY WITH OR WITHOUT INTERNAL LIMITING MEMBRANE PEELING TO PREVENT POSTOPERATIVE MACULAR PUCKER. Retina. 2018 Sep;38(9):1770-1776. doi: 10.1097/IAE.0000000000001775.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ILM-Peeling and No Peeling in people with Retinal Detachment, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Peeling of the internal limiting membrane has shown risks to leave full thickness retinal defects). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual acuity (time frame: from enrollment to the end of follow-up at 4 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07438210, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.