Idiopathic Epiretinal MembranesNCT07142785
Clinical Evaluation of With or Without Internal Limiting Membrane Peeling for Idiopathic Epiretinal Membrane Surgery: A Randomized Controlled Trial
A study testing Epiretinal membrane peeling and Epiretinal membrane peeling combined with internal limiting membrane peeling in people with Idiopathic Epiretinal Membranes, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Idiopathic epiretinal membrane (ERM) is an age-related degenerative retinal condition. One of the primary treatment approaches is vitrectomy combined with epiretinal membrane peeling. However, whether to concurrently perform internal limiting membrane (ILM) peeling remains clinically controversial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Epiretinal Membranes
- What is being tested?
- Epiretinal membrane peeling and Epiretinal membrane peeling combined with internal limiting membrane peeling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients aged >18 years presenting to our hospital within the study period.
- Patients diagnosed with idiopathic epiretinal membrane (ERM) based on examination.
- Patients with best-corrected visual acuity (BCVA) ≤ 0.6 or the presence of metamorphopsia.
Who cannot join
- Patients with secondary ERM identified during preoperative evaluation (e.g., secondary to retinal vein occlusion).
- Patients with concomitant ocular diseases affecting the macula, such as macular degeneration, macular schisis, or macular atrophy.
- Patients with a history of ocular trauma or previous ocular surgery (except for cataract surgery).
- Patients with severe systemic diseases contraindicated for surgery.
- Patients with poor compliance or concomitant psychiatric disorders.
- Patients who participated in other clinical trials during the follow-up period or who were lost to follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Eye Center of the Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310058
Yueyang Zhong, 18868125901, yyzbzhong@zju.edu.cn
About this study
Idiopathic epiretinal membrane (ERM) is an age-related degenerative retinal condition. One of the primary treatment approaches is vitrectomy combined with epiretinal membrane peeling. However, whether to concurrently perform internal limiting membrane (ILM) peeling remains clinically controversial. Therefore, this study aims to compare the efficacy and safety of performing versus omitting ILM peeling during idiopathic ERM surgery.
Read the detailed description
Idiopathic epiretinal membrane (ERM) is an age-related degenerative retinal condition. Its pathological hallmark is the formation of a fibrocellular membrane in the macular region, which can lead to retinal structural distortion and visual impairment. Epidemiological studies indicate that ERM is age-related, occurs more frequently unilaterally, and shows a positive correlation with advancing age, with incidence rates of 2% to 20% in individuals aged 50 to 70 years. The severity primarily depends on the location and thickness of the membrane and the presence of macular pseudoholes, manifesting as symptoms including visual field distortion (metamorphopsia), micropsia, and central vision loss. Studies suggest that ERM patients experiencing progressive visual decline, best-corrected visual acuity (BCVA) ≤ 0.6, or severe metamorphopsia require surgical intervention. There remains a lack of high-quality prospective RCTs evaluating the therapeutic outcomes of vitrectomy combined with ERM peeling with or without ILM peeling in idiopathic ERM patients. Therefore, this study aims to compare the efficacy and safety of performing versus omitting ILM peeling during idiopathic ERM surgery.
- Conditions
- Idiopathic Epiretinal Membranes
- Being tested
- Epiretinal membrane peeling, Epiretinal membrane peeling combined with internal limiting membrane peeling
- Keywords
- Idiopathic epiretinal membrane, internal limiting membrane, visual field, randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epiretinal membrane peelingProcedure or surgery
All patients will receive standard pars plana vitrectomy, followed by only epiretinal membrane peeling.
Epiretinal membrane peeling combined with internal limiting membrane peelingProcedure or surgery
All patients will receive standard pars plana vitrectomy, followed by epiretinal membrane peeling and internal limiting membrane peeling.
| Study group | Role | What they receive |
|---|---|---|
| Internal limiting membrane (ILM) peeling group | Experimental | The patients will receive standard pars plana vitrectomy with ERM peeling combined with ILM peeling within an area of 3-4 disc diameters centered on the macula. Receives: Procedure: Epiretinal membrane peeling combined with internal limiting membrane peeling |
| No ILM peeling group | Active comparator | The patients will receive standard pars plana vitrectomy with only ERM peeling Receives: Procedure: Epiretinal membrane peeling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean deviation (MD) value
mean deviation (MD) value from postoperative Humphrey visual field testing.
Measured: 6 months postoperatively
Secondary outcomes (3)
Visual acuity
uncorrected and corrected distance visual acuity
Measured: 6 months postoperatively
Ganglion cell complex
Ganglion cell complex parameters on macular OCT
Measured: 6 months postoperatively
Recurrence rate
Recurrence rate of ERM
Measured: 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Epiretinal MembranesStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- 96 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142785
- Sponsor's protocol ID
- 20250974
- Status last verified
- Jul 2025
- First submitted
- 20 Jul 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of With or Without Internal Limiting Membrane Peeling for Idiopathic Epiretinal Membrane Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07142785
- Acronym / sponsor ID
- 20250974
- Conditions
- Idiopathic Epiretinal Membranes
- Keywords
- Idiopathic epiretinal membrane, internal limiting membrane, visual field, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 27 Aug 2025 (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.
Idiopathic epiretinal membrane (ERM) is an age-related degenerative retinal condition. One of the primary treatment approaches is vitrectomy combined with epiretinal membrane peeling. However, whether to concurrently perform internal limiting membrane (ILM) peeling remains clinically controversial. Therefore, this study aims to compare the efficacy and safety of performing versus omitting ILM peeling during idiopathic ERM surgery.
Detailed description
Idiopathic epiretinal membrane (ERM) is an age-related degenerative retinal condition. Its pathological hallmark is the formation of a fibrocellular membrane in the macular region, which can lead to retinal structural distortion and visual impairment. Epidemiological studies indicate that ERM is age-related, occurs more frequently unilaterally, and shows a positive correlation with advancing age, with incidence rates of 2% to 20% in individuals aged 50 to 70 years. The severity primarily depends on the location and thickness of the membrane and the presence of macular pseudoholes, manifesting as symptoms including visual field distortion (metamorphopsia), micropsia, and central vision loss. Studies suggest that ERM patients experiencing progressive visual decline, best-corrected visual acuity (BCVA) ≤ 0.6, or severe metamorphopsia require surgical intervention. There remains a lack of high-quality prospective RCTs evaluating the therapeutic outcomes of vitrectomy combined with ERM peeling with or without ILM peeling in idiopathic ERM patients. Therefore, this study aims to compare the efficacy and safety of performing versus omitting ILM peeling during idiopathic ERM surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internal limiting membrane (ILM) peeling group | Experimental | Procedure: Epiretinal membrane peeling combined with internal limiting membrane peelingThe patients will receive standard pars plana vitrectomy with ERM peeling combined with ILM peeling within an area of 3-4 disc diameters centered on the macula. |
| No ILM peeling group | Active comparator | Procedure: Epiretinal membrane peelingThe patients will receive standard pars plana vitrectomy with only ERM 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)
- Patients aged >18 years presenting to our hospital within the study period.
- Patients diagnosed with idiopathic epiretinal membrane (ERM) based on examination.
- Patients with best-corrected visual acuity (BCVA) ≤ 0.6 or the presence of metamorphopsia.
Key exclusion criteria (6 listed)
- Patients with secondary ERM identified during preoperative evaluation (e.g., secondary to retinal vein occlusion).
- Patients with concomitant ocular diseases affecting the macula, such as macular degeneration, macular schisis, or macular atrophy.
- Patients with a history of ocular trauma or previous ocular surgery (except for cataract surgery).
- Patients with severe systemic diseases contraindicated for surgery.
- Patients with poor compliance or concomitant psychiatric disorders.
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 |
|---|---|---|
| Epiretinal membrane peelingAll patients will receive standard pars plana vitrectomy, followed by only epiretinal membrane peeling. | Procedure or surgery | No ILM peeling group |
| Epiretinal membrane peeling combined with internal limiting membrane peelingAll patients will receive standard pars plana vitrectomy, followed by epiretinal membrane peeling and internal limiting membrane peeling. | Procedure or surgery | Internal limiting membrane (ILM) peeling group |
Primary outcome
Mean deviation (MD) value
Time frame: 6 months postoperatively
mean deviation (MD) value from postoperative Humphrey visual field testing.
3 secondary outcomes
Visual acuity
Time frame: 6 months postoperatively
Ganglion cell complex
Time frame: 6 months postoperatively
Recurrence rate
Time frame: 12 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Individual participant dataSharing planned: No
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Enrolling by invitation
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epiretinal membrane peeling and Epiretinal membrane peeling combined with internal limiting membrane peeling in people with Idiopathic Epiretinal Membranes, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 6 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: looking for participants now, as of the sponsor's last update on 27 Aug 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yueyang Zhong, MD. (+8618868125901, yyzbzhong@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean deviation (MD) value (time frame: 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2025.