Post-surgical Functional Results in Patients With Epiretinal Membrane Undergoing Controlled Macular Detachment

Официальное название

Post-surgical Functional Results in Patients With Epiretinal Membrane Undergoing Controlled Macular Detachment: Pilot Study.

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Pars plana vitrectomy with epiretinal membrane peeling and controlled macular detachment
  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.

Первичные конечные точки

• BCVA (Best corrected visual acuity) [Срок оценки: From the first recruitment evaluation to the last one at 3 months post-surgery]

Вторичные конечные точки (3)

• Postoperative anatomical changes of the macula using optical coherence tomography: Central macular thickness (µm) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: From enrollment to the end of follow-up at the third month.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Мексика · 1 центр

• Hospital Asociación Para Evitar la Ceguera en México I.A.P. — Mexico City

Публикации

• 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. PMID 36880022
• Chang 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. PMID 28622372
• Khanna 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. PMID 35169203
• Flaxel 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. PMID 31757497
• Morizane 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. PMID 26220819
• Szurman 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. PMID 17065517
• Momota 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. PMID 32764657
• Choi 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. PMID 38117309

Идентификаторы

NCT: NCT07095907 · RE-25-09

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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