Epiretinal Membrane SurgeryDMER25NCT07095907
Post-surgical Functional Results in Patients With Epiretinal Membrane Undergoing Controlled Macular Detachment
A study of Epiretinal Membrane Surgery, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
Trial summary
This study aims to evaluate postsurgical functional changes in patients with advanced epiretinal membrane (ERM) (stages 3 and 4) by integrating a controlled macular detachment with a balanced salt solution to the conventional ERM peeling technique. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epiretinal Membrane Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteMexico
- Study dates
- 10 Jun 2025to 26 Jan 2026
- 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 over 18 years of age.
- Patients with a confirmed diagnosis of ERM grade III or IV by Optical Coherence Tomography who present visual disturbances such as metamorphopsia or visual impairment (measured in letters on the ETDRS scale) but who do not reflect end-stage visual impairment.
- Patients suitable for vitreoretinal surgical procedures, with no uncontrolled medical comorbidities that contraindicate surgery.
- Patients who understand the objectives and risks of the study and sign an informed consent form.
Who cannot join
- Patients with a confirmed diagnosis of grade III or IV ERM by Optical Coherence Tomography who do not have the ability to improve their visual acuity.
- Patients diagnosed with ocular pathologies that significantly affect their visual acuity, such as moderate or advanced glaucoma, non-glaucomatous optic neuropathies, or optic media opacities such as leukomas, significant corneal edema, or other maculopathies such as macular atrophy or macular ischemia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Hospital Asociación Para Evitar la Ceguera en México I.A.P.
Mexico City, 04030
Oriana Gomez, MD, 52 5510841400 ext. 1302, orianagomezerazo@gmail.com
Raul Velez, MD
About this study
Official title: Post-surgical Functional Results in Patients With Epiretinal Membrane Undergoing Controlled Macular Detachment: Pilot Study.
This study aims to evaluate postsurgical functional changes in patients with advanced epiretinal membrane (ERM) (stages 3 and 4) by integrating a controlled macular detachment with a balanced salt solution to the conventional ERM peeling technique.
Read the detailed description
The evolution of visual acuity will be analyzed using the ETDRS letter scale. At the same time, anatomical and microvascular changes will be evaluated using optical coherence tomography (OCT) and optical coherence tomography angiography (OCT-A) to evaluate their impact on visual recovery. This technique is expected to minimize persistent distortion, promote restoration of retinal perfusion, mitigate postoperative ischemia, and improve macular structural stability, potentially leading to more significant functional recovery. It is designed as a prospective longitudinal pilot study; The research will be carried out in the Retina Department of the Association to Prevent Blindness in Mexico (APEC), focusing on patients over 18 years of age with a diagnosis of advanced MRD and eligible for vitreoretinal surgery.
- Conditions
- Epiretinal Membrane Surgery
- Being tested
- Pars plana vitrectomy with epiretinal membrane peeling and controlled macular detachment
- Keywords
- Epiretinal membrane, Epiretinal membrane surgery, Macular detachment
- Medical subject headings
- Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pars plana vitrectomy with epiretinal membrane peeling and controlled macular detachmentProcedure or surgery
Currently, vitrectomy with epiretinal membrane peeling is the standard procedure; however, its ability to improve visual acuity in these patients remains limited. In this context, controlled macular detachment is emerging as a surgical alternative that could optimize the anatomical and functional restoration of the retina.
| Study group | Role | What they receive |
|---|---|---|
| Patient protocol | Experimental | Patients over 18 years of age, with a clinical diagnosis of Epiretinal Membrane grade 3 and 4 according to Optical Coherence Tomography, who attend the Retina service. Receives: Procedure: Pars plana vitrectomy with epiretinal membrane peeling and controlled macular detachment |
What is being measured
The primary outcome is the main question the study is designed to answer.
BCVA (Best corrected visual acuity)
Ability to discriminate fine details at a standard distance, assessed by reading letters on an ETDRS chart.
Measured: From the first recruitment evaluation to the last one at 3 months post-surgery
Secondary outcomes (3)
Postoperative anatomical changes of the macula using optical coherence tomography: Central macular thickness (µm)
Central macular thickness measured in microns (µm)
Measured: From enrollment to the end of follow-up at the third month.
Postoperative anatomical changes of the macula using optical coherence tomography: Inner nuclear layer thickness (µm)
Inner nuclear layer thickness measured in microns (µm)
Measured: From enrollment to the end of follow-up at the third month.
Postoperative anatomical changes of the macula using optical coherence tomography: Ellipsoid zone disruption
Presence or absence of disruption of the Ellipsoid layer
Measured: From enrollment to the end of follow-up at the third month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start10 Jun 2025
- Primary completion17 Dec 2025 (estimated)
- Study completion26 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Epiretinal Membrane SurgeryStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, Longitudinal, Experimental, Descriptive Cohort Study.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asociación para Evitar la Ceguera en México
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raul Velez, MD, Principal investigator, Asociación para Evitar la Ceguera en México
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095907
- Sponsor's protocol ID
- RE-25-09
- Acronym
- DMER25
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abu-Ain M, Shatnawi R, Shehadeh I, Khan MI. Long-Term Visual Acuity and Optical Coherence Tomography Changes After Vitrectomy for Idiopathic Epiretinal Membranes. Clin Ophthalmol. 2023 Feb 28;17:693-700. doi: 10.2147/OPTH.S401017. eCollection 2023.
PubMed 36880022Chang WC, Lin C, Lee CH, Sung TL, Tung TH, Liu JH. Vitrectomy with or without internal limiting membrane peeling for idiopathic epiretinal membrane: A meta-analysis. PLoS One. 2017 Jun 16;12(6):e0179105. doi: 10.1371/journal.pone.0179105. eCollection 2017.
PubMed 28622372Khanna RK, Dorvault M, Pasco J, Cook AR, Pichard T, Marotte MT, Pisella PJ, Arsene S. Long-term functional outcomes and vision-related quality of life after vitrectomy for epiretinal membrane: a prospective cohort study. Sci Rep. 2022 Feb 15;12(1):2470. doi: 10.1038/s41598-022-06482-3.
PubMed 35169203Flaxel CJ, Adelman RA, Bailey ST, Fawzi A, Lim JI, Vemulakonda GA, Ying GS. Idiopathic Epiretinal Membrane and Vitreomacular Traction Preferred Practice Pattern(R). Ophthalmology. 2020 Feb;127(2):P145-P183. doi: 10.1016/j.ophtha.2019.09.022. Epub 2019 Sep 25. No abstract available.
PubMed 31757497Morizane Y, Kimura S, Hosokawa M, Shiode Y, Hirano M, Doi S, Hosogi M, Fujiwara A, Inoue Y, Shiraga F. Planned foveal detachment technique for the resolution of diffuse diabetic macular edema. Jpn J Ophthalmol. 2015 Sep;59(5):279-87. doi: 10.1007/s10384-015-0390-4. Epub 2015 Jul 30.
PubMed 26220819Szurman P, Roters S, Grisanti S, Aisenbrey S, Schraermeyer U, Luke M, Bartz-Schmidt KU, Thumann G. Ultrastructural changes after artificial retinal detachment with modified retinal adhesion. Invest Ophthalmol Vis Sci. 2006 Nov;47(11):4983-9. doi: 10.1167/iovs.06-0491.
PubMed 17065517Momota A, Iwase T, Akahori T, Goto K, Yamamoto K, Ra E, Terasaki H. Association between displacement and thickness of macula after vitrectomy in eyes with epiretinal membrane. Sci Rep. 2020 Aug 6;10(1):13227. doi: 10.1038/s41598-020-70197-6.
PubMed 32764657Choi KE, Kim S, Kim SW. Anatomical changes in idiopathic epiretinal membrane at 2-year follow-up assessed using spectral domain optical coherence tomography and optical coherence tomographic angiography. Graefes Arch Clin Exp Ophthalmol. 2024 May;262(5):1465-1474. doi: 10.1007/s00417-023-06332-6. Epub 2023 Dec 20.
PubMed 38117309Bacherini D, Dragotto F, Caporossi T, Lenzetti C, Finocchio L, Savastano A, Savastano MC, Barca F, Dragotto M, Vannozzi L, Nasini F, Faraldi F, Rizzo S, Virgili G, Giansanti F. The Role of OCT Angiography in the Assessment of Epiretinal Macular Membrane. J Ophthalmol. 2021 Mar 24;2021:8866407. doi: 10.1155/2021/8866407. eCollection 2021.
PubMed 33815835Baldascino A, Carla MM, Vielmo L, Gambini G, Marzano FC, Margollicci F, D'Onofrio NC, Rizzo S. Microvascular Changes after Epiretinal Membrane Vitrectomy with Intraoperative Intravitreal Dexamethasone Implant: An OCT Angiography Analysis. Diagnostics (Basel). 2024 Feb 13;14(4):411. doi: 10.3390/diagnostics14040411.
PubMed 38396450Wong R, Howard C, Orobona GD. RETINA EXPANSION TECHNIQUE FOR MACULAR HOLE APPOSITION REPORT 2: Efficacy, Closure Rate, and Risks of a Macular Detachment Technique to Close Large Full-Thickness Macular Holes. Retina. 2018 Apr;38(4):660-663. doi: 10.1097/IAE.0000000000001705.
PubMed 28816729Yang HS, Choi S, Kim S, Min CH, Kim D, Lee Y, Kim M, Koo D, Ryu J, Kim J. Epiretinal Membrane: Correlations Among Clinical, Immunohistochemical, and Biochemical Features and Their Prognostic Implications. Invest Ophthalmol Vis Sci. 2024 Dec 2;65(14):25. doi: 10.1167/iovs.65.14.25.
PubMed 39661356Miyazato M, Iwashita Y, Hirono K, Ching J, Nakamura K, Inoue T, Asaoka R, Yanagi Y, Maruyama-Inoue M, Kadonosono K. Predictive factors for postoperative visual function in eyes with epiretinal membrane. Sci Rep. 2023 Dec 14;13(1):22198. doi: 10.1038/s41598-023-49689-8.
PubMed 38097656Govetto A, Virgili G, Rodriguez FJ, Figueroa MS, Sarraf D, Hubschman JP. FUNCTIONAL AND ANATOMICAL SIGNIFICANCE OF THE ECTOPIC INNER FOVEAL LAYERS IN EYES WITH IDIOPATHIC EPIRETINAL MEMBRANES: Surgical Results at 12 Months. Retina. 2019 Feb;39(2):347-357. doi: 10.1097/IAE.0000000000001940.
PubMed 29160787Govetto A, Lalane RA 3rd, Sarraf D, Figueroa MS, Hubschman JP. Insights Into Epiretinal Membranes: Presence of Ectopic Inner Foveal Layers and a New Optical Coherence Tomography Staging Scheme. Am J Ophthalmol. 2017 Mar;175:99-113. doi: 10.1016/j.ajo.2016.12.006. Epub 2016 Dec 18.
PubMed 27993592
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-surgical Functional Results in Patients With Epiretinal Membrane Undergoing Controlled Macular Detachment: Pilot Study.
- ClinicalTrials.gov ID
- NCT07095907
- Acronym / sponsor ID
- DMER25 / RE-25-09
- Conditions
- Epiretinal Membrane Surgery
- Keywords
- Epiretinal membrane, Epiretinal membrane surgery, Macular detachment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Asociación para Evitar la Ceguera en MéxicoUniversity, hospital or other
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- 17 Dec 2025 (estimated)
- Study completion
- 26 Jan 2026 (estimated)
- First posted
- 31 Jul 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.
This study aims to evaluate postsurgical functional changes in patients with advanced epiretinal membrane (ERM) (stages 3 and 4) by integrating a controlled macular detachment with a balanced salt solution to the conventional ERM peeling technique.
Detailed description
The evolution of visual acuity will be analyzed using the ETDRS letter scale. At the same time, anatomical and microvascular changes will be evaluated using optical coherence tomography (OCT) and optical coherence tomography angiography (OCT-A) to evaluate their impact on visual recovery. This technique is expected to minimize persistent distortion, promote restoration of retinal perfusion, mitigate postoperative ischemia, and improve macular structural stability, potentially leading to more significant functional recovery. It is designed as a prospective longitudinal pilot study; The research will be carried out in the Retina Department of the Association to Prevent Blindness in Mexico (APEC), focusing on patients over 18 years of age with a diagnosis of advanced MRD and eligible for vitreoretinal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, Longitudinal, Experimental, Descriptive Cohort Study.
| Arm | Type | Receives |
|---|---|---|
| Patient protocol | Experimental | Procedure: Pars plana vitrectomy with epiretinal membrane peeling and controlled macular detachmentPatients over 18 years of age, with a clinical diagnosis of Epiretinal Membrane grade 3 and 4 according to Optical Coherence Tomography, who attend the Retina service. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients over 18 years of age.
- Patients with a confirmed diagnosis of ERM grade III or IV by Optical Coherence Tomography who present visual disturbances such as metamorphopsia or visual impairment (measured in letters on the ETDRS scale) but who do not reflect end-stage visual impairment.
- Patients suitable for vitreoretinal surgical procedures, with no uncontrolled medical comorbidities that contraindicate surgery.
- Patients who understand the objectives and risks of the study and sign an informed consent form.
Key exclusion criteria (2 listed)
- Patients with a confirmed diagnosis of grade III or IV ERM by Optical Coherence Tomography who do not have the ability to improve their visual acuity.
- Patients diagnosed with ocular pathologies that significantly affect their visual acuity, such as moderate or advanced glaucoma, non-glaucomatous optic neuropathies, or optic media opacities such as leukomas, significant corneal edema, or other maculopathies such as macular atrophy or macular ischemia.
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 |
|---|---|---|
| Pars plana vitrectomy with epiretinal membrane peeling and controlled macular detachmentCurrently, vitrectomy with epiretinal membrane peeling is the standard procedure; however, its ability to improve visual acuity in these patients remains limited. In this context, controlled macular detachment is emerging as a surgical alternative that could optimize the anatomical and functional restoration of the retina. | Procedure or surgery | Patient protocol |
Primary outcome
BCVA (Best corrected visual acuity)
Time frame: From the first recruitment evaluation to the last one at 3 months post-surgery
Ability to discriminate fine details at a standard distance, assessed by reading letters on an ETDRS chart.
3 secondary outcomes
Postoperative anatomical changes of the macula using optical coherence tomography: Central macular thickness (µm)
Time frame: From enrollment to the end of follow-up at the third month.
Postoperative anatomical changes of the macula using optical coherence tomography: Inner nuclear layer thickness (µm)
Time frame: From enrollment to the end of follow-up at the third month.
Postoperative anatomical changes of the macula using optical coherence tomography: Ellipsoid zone disruption
Time frame: From enrollment to the end of follow-up at the third month.
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 31 Jul 2025.
- Background: PubMed 36880022Abu-Ain M, Shatnawi R, Shehadeh I, Khan MI. Long-Term Visual Acuity and Optical Coherence Tomography Changes After Vitrectomy for Idiopathic Epiretinal Membranes. Clin Ophthalmol. 2023 Feb 28;17:693-700. doi: 10.2147/OPTH.S401017. eCollection 2023.
- Background: PubMed 28622372Chang WC, Lin C, Lee CH, Sung TL, Tung TH, Liu JH. Vitrectomy with or without internal limiting membrane peeling for idiopathic epiretinal membrane: A meta-analysis. PLoS One. 2017 Jun 16;12(6):e0179105. doi: 10.1371/journal.pone.0179105. eCollection 2017.
- Background: PubMed 35169203Khanna RK, Dorvault M, Pasco J, Cook AR, Pichard T, Marotte MT, Pisella PJ, Arsene S. Long-term functional outcomes and vision-related quality of life after vitrectomy for epiretinal membrane: a prospective cohort study. Sci Rep. 2022 Feb 15;12(1):2470. doi: 10.1038/s41598-022-06482-3.
- Background: PubMed 31757497Flaxel CJ, Adelman RA, Bailey ST, Fawzi A, Lim JI, Vemulakonda GA, Ying GS. Idiopathic Epiretinal Membrane and Vitreomacular Traction Preferred Practice Pattern(R). Ophthalmology. 2020 Feb;127(2):P145-P183. doi: 10.1016/j.ophtha.2019.09.022. Epub 2019 Sep 25. No abstract available.
- Background: PubMed 26220819Morizane Y, Kimura S, Hosokawa M, Shiode Y, Hirano M, Doi S, Hosogi M, Fujiwara A, Inoue Y, Shiraga F. Planned foveal detachment technique for the resolution of diffuse diabetic macular edema. Jpn J Ophthalmol. 2015 Sep;59(5):279-87. doi: 10.1007/s10384-015-0390-4. Epub 2015 Jul 30.
- Background: PubMed 17065517Szurman P, Roters S, Grisanti S, Aisenbrey S, Schraermeyer U, Luke M, Bartz-Schmidt KU, Thumann G. Ultrastructural changes after artificial retinal detachment with modified retinal adhesion. Invest Ophthalmol Vis Sci. 2006 Nov;47(11):4983-9. doi: 10.1167/iovs.06-0491.
- Background: PubMed 32764657Momota A, Iwase T, Akahori T, Goto K, Yamamoto K, Ra E, Terasaki H. Association between displacement and thickness of macula after vitrectomy in eyes with epiretinal membrane. Sci Rep. 2020 Aug 6;10(1):13227. doi: 10.1038/s41598-020-70197-6.
- Background: PubMed 38117309Choi KE, Kim S, Kim SW. Anatomical changes in idiopathic epiretinal membrane at 2-year follow-up assessed using spectral domain optical coherence tomography and optical coherence tomographic angiography. Graefes Arch Clin Exp Ophthalmol. 2024 May;262(5):1465-1474. doi: 10.1007/s00417-023-06332-6. Epub 2023 Dec 20.
- Background: PubMed 33815835Bacherini D, Dragotto F, Caporossi T, Lenzetti C, Finocchio L, Savastano A, Savastano MC, Barca F, Dragotto M, Vannozzi L, Nasini F, Faraldi F, Rizzo S, Virgili G, Giansanti F. The Role of OCT Angiography in the Assessment of Epiretinal Macular Membrane. J Ophthalmol. 2021 Mar 24;2021:8866407. doi: 10.1155/2021/8866407. eCollection 2021.
- Background: PubMed 38396450Baldascino A, Carla MM, Vielmo L, Gambini G, Marzano FC, Margollicci F, D'Onofrio NC, Rizzo S. Microvascular Changes after Epiretinal Membrane Vitrectomy with Intraoperative Intravitreal Dexamethasone Implant: An OCT Angiography Analysis. Diagnostics (Basel). 2024 Feb 13;14(4):411. doi: 10.3390/diagnostics14040411.
- Background: PubMed 28816729Wong R, Howard C, Orobona GD. RETINA EXPANSION TECHNIQUE FOR MACULAR HOLE APPOSITION REPORT 2: Efficacy, Closure Rate, and Risks of a Macular Detachment Technique to Close Large Full-Thickness Macular Holes. Retina. 2018 Apr;38(4):660-663. doi: 10.1097/IAE.0000000000001705.
- Background: PubMed 39661356Yang HS, Choi S, Kim S, Min CH, Kim D, Lee Y, Kim M, Koo D, Ryu J, Kim J. Epiretinal Membrane: Correlations Among Clinical, Immunohistochemical, and Biochemical Features and Their Prognostic Implications. Invest Ophthalmol Vis Sci. 2024 Dec 2;65(14):25. doi: 10.1167/iovs.65.14.25.
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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.
Raul Velez, MD principal investigator
Asociación para Evitar la Ceguera en México
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Epiretinal Membrane Surgery, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
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 4 inclusion and 2 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 31 Jul 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 Mexico. 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 Raúl Velez Montoya, MD ((52) 55 5436 7335, rvelezmx@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BCVA (Best corrected visual acuity) (time frame: From the first recruitment evaluation to the last one at 3 months post-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 NCT07095907, which also lists 22 linked publications.
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 31 Jul 2025.