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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05993208
Other study ID # CBOCT&MFERG&VA-VRD
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date November 15, 2023

Study information

Verified date August 2023
Source New Valley University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date November 15, 2023
Est. primary completion date May 1, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt New Vally University Sohag

Sponsors (2)

Lead Sponsor Collaborator
New Valley University Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary CMT,BCVAand mf-ERG were recoreded in 40 eyes of 40 patintes with vitrectomy for retinal detchament surgery . 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 . 6 months
Primary BCVA(best corrected visual acuity) Best corrected Visual acuity measurement using Snellen's Acuity Chart and will be expressed as decimal notation 6 Month
Primary CMT(central macualr thikness ) um centeral macualr thikness mesurment using using optical chorent tomgraphgy 6 month
Primary mf-ERG amplituide nV/deg2 multifocal electroretinogram amplituide mesurement using mf-ERG machine 6 month
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