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NCT04802915 Clinical Trial

Intraoperative Analysis of the Central Retina in ERF

Epiretinal Membrane Clinical Trial

Official title:
Intraoperative Analysis of the Central Retina in Epiretinal Fibrosis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04802915
Other study ID # 124575
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 15, 2019
Est. completion date December 2022

Study information
Verified date March 2021
Source The S.N. Fyodorov Eye Microsurgery State Institution
Contact Pavel V Lyskin, PhD
Phone +74994888926
Email plyskin@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Changes in the retinal anatomy that occur in epiretinal fibrosis have not been sufficiently studied. It is possible that epiretinal fibrosis leads not only to traction dislocation of the macula, but also to ILM anatomical disorders.

Description:

Purpose: to study anatomical changes in the Central retina in epiretinal fibrosis. Surgical treatment: standard vitrectomy 25-27G; ERM amd ILM stainig by Membrane Blue Dual; epiretinal membrane removal, ILM peeling if the divulsion of ILM was detected. Expected results: improving the quality of epiretinal fibrosis surgery by obtaining a more detailed picture of the pathological process

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date December 2022
Est. primary completion date January 2022
Accepts healthy volunteers No
Gender All
Age group 50 Years to 82 Years
Eligibility Inclusion Criteria: - BCVA < 0,6; Exclusion Criteria:. - secondary ERM, glaucoma, diabetic retinopathy, high myopia, BCVA>0,6

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Intraoperative ERM and ILM staining with their assessment and removal
ERM and ILM staining is performed after vitrectomy. After that we evaluate the condition of macular zone and make a decision to remove the ERM and the need to remove the ILM

Locations
Country Name City State
Russian Federation S.N. Fedorov Nmrc "Mntk "Eye Microsurgery" Moscow

Sponsors (3)
Lead Sponsor Collaborator
The S.N. Fyodorov Eye Microsurgery State Institution Makarenko Irina Romanovna, Zgoba Mariana Igorevna

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary ILM integrity Visual intraoperative assessment of the ILM integrity intraoperative
Primary Length and localization of the ILM dialysis Length (in degrees) and localization of the ILM dyalisis intraoperative
Primary ILM displacement ILM displacement direction during the formation of detachment and divulsion. intraoperative
Primary Occurence of ILM dyalisis Determination of the ratio of patients with ILM dialysis to the total number of patients with ERF intraoperative
See also
  Status Clinical Trial Phase
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Active, not recruiting NCT04130841 - Effects of Internal Limiting Membrane Peeling on Visual Function in Epiretinal Membrane Surgery N/A
Recruiting NCT03713268 - Intraoperative OCT Guidance of Intraocular Surgery II
Terminated NCT01532765 - Randomized Trial Comparing Epiretinal Membrane Surgery With and Without Internal Limiting Membrane Removal N/A
Completed NCT01474655 - Retinal Layers and Visual Rehabilitation After Epiretinal Membrane Removal N/A
Active, not recruiting NCT04120311 - Episcleral Dexamethasone for Treatment of Macular Edema and Inflammatory Disorders of the Posterior Pole Phase 1
Completed NCT04445142 - Fovea ERM After Fovea-sparing ILM Peeling
Recruiting NCT01701518 - A Pilot Study of the Effectiveness of Intra-operative Ozurdex® in Vitrectomy Surgery for Epiretinal Membranes N/A
Completed NCT01627977 - Association of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy Phase 3
Completed NCT01771939 - Phacoemulsification and 25 Gauge (25G) Vitrectomy Versus Phacoemulsification Only in Idiopathic Epiretinal Membranes N/A
Completed NCT00408720 - Comparison of a Spectral OCT/SLO With the Stratus OCT for Imaging Various Retinal Pathologies N/A
Completed NCT05171621 - Measuring Subjective Quality of Vision and Metamorphopsia Before and After Epiretinal Membrane and Macular Hole Surgery
Active, not recruiting NCT04306718 - Cultivation of Hyalocytes From ILM and ERM Samples: a Pilot Study N/A
Recruiting NCT01985490 - Change in Foveal Avascular Zone After Removal of Epiretinal Membrane and Internal Limiting Membrane N/A
Completed NCT01238393 - Treatment of Epiretinal Membranes With Ranibizumab N/A
Terminated NCT00333060 - Study of OT-551 Eye Drops to Prevent or Delay Progression of Nuclear Cataracts Following Vitreous Removal Phase 2
Completed NCT05287269 - Ocular Coherence Tomography During Cataract Assessment
Recruiting NCT05138315 - Quantification of Metamorphopsia in Patients With Epiretinal Membranes N/A
Recruiting NCT03661593 - Aniseikonia in Epiretinal Membrane Patients N/A
Completed NCT03457584 - Effect of Air-tamponade on Intraretinal Cystoid Changes After Membrane Peeling N/A

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