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Correlation Between OCT and mFERG Findings With VA After Vitrectomy Surgery for Retinal Detachment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05993208
Recruitment Status : Completed
First Posted : August 15, 2023
Last Update Posted : December 12, 2023
Sponsor:
Collaborator:
Assiut University
Information provided by (Responsible Party):
Asmaa Kamel Ahmed Hassan, New Valley University

Brief Summary:
Correlation between optical coherence tomography and multifocal electroretinogram findings with visual acuity after vitrectomy surgery for Retinal detachment.

Condition or disease Intervention/treatment
Retinal Detachment Diagnostic Test: optical coherence tomography,multifocal electroretinogram. VA measurment

Detailed Description:

Although the anatomical success rate of vitreoretinal surgery has improved over the last decade, visual results remain compromised? Patients with macula-off retinal detachments (RDs) can have poor visual recovery, specific color vision defects, or metamorphopsia postoperatively despite successful retinal reattachment. In these cases, subtle changes in the foveal structure may be causing visual disturbances that can be difficult to identify during standard clinical examinations such as slit lamp biomicroscopy or binocular indirect ophthalmoscopy .reported a possible association between incomplete visual recovery and the presence of residual subretinal fluid (SRF) postoperatively.

Optical coherence tomography (OCT) is a non-invasive technique that provides information about the morphology of the retina, and especially of the macular area in vivo. Some studies support the idea that OCT determines structural changes in the macula that are correlated with subjective visual function, including visual acuity (VA) in patients with vitrectomy for retinal detachment. Additionally, multifocal electroretinogram (m fERG) evaluation can be helpful in assessing macular function in post-vitrectomy. However, to date, there are relatively few reports concerning the combined use of OCT and m fERG for the correlation between retinal morphology and function of the macula in patients with vitrectomy for retinal detachment surgery. The purpose of our study is to determine whether a significant correlation exists between the amplitude of m fERG, visual acuity, and the morphological OCT changes by in the macula after vitrectomy for retinal detachment

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Correlation Between Optical Coherence Tomography and Multifocal Electroretinogram Findings With Visual Acuity After Vitrectomy Surgery for Retinal Detachment
Actual Study Start Date : January 1, 2023
Actual Primary Completion Date : May 1, 2023
Actual Study Completion Date : November 15, 2023

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: optical coherence tomography,multifocal electroretinogram. VA measurment
    retinal photography


Primary Outcome Measures :
  1. CMT,BCVAand mf-ERG were recoreded in 40 eyes of 40 patintes with vitrectomy for retinal detchament surgery . [ Time Frame: 6 months ]
    Each 10 um increase in central (CMT) associated by how increase decimal in Best corrected visual acuity and by how nV/deg2 increase multifocal electroretinogram in these eyes .

  2. BCVA(best corrected visual acuity) [ Time Frame: 6 Month ]
    Best corrected Visual acuity measurement using Snellen's Acuity Chart and will be expressed as decimal notation

  3. CMT(central macualr thikness ) um [ Time Frame: 6 month ]
    centeral macualr thikness mesurment using using optical chorent tomgraphgy

  4. mf-ERG amplituide nV/deg2 [ Time Frame: 6 month ]
    multifocal electroretinogram amplituide mesurement using mf-ERG machine



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Retrospective observation (analytic) study
Criteria

Inclusion Criteria:

  • patients with successful vitrectomy for retinal detachment.

Exclusion Criteria:

  • The patients who had vitrectomy for reasons other than retinal detachment surgery
  • Patients who had done scleral buckle surgery
  • Patients with media opacity are prevented from doing retina imaging.
  • Failed or recurrent vitrectomy surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05993208


Locations
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Egypt
New Vally University
Sohag, Egypt
Sponsors and Collaborators
New Valley University
Assiut University
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Responsible Party: Asmaa Kamel Ahmed Hassan, lecture, New Valley University
ClinicalTrials.gov Identifier: NCT05993208    
Other Study ID Numbers: CBOCT&MFERG&VA-VRD
First Posted: August 15, 2023    Key Record Dates
Last Update Posted: December 12, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Retinal Detachment
Dissociative Disorders
Mental Disorders
Retinal Diseases
Eye Diseases