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CompletedNCT05993208Updated Dec 12, 2023

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

An observational study in Retinal Detachment, sponsored by New Valley University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2023-12-12.

Sponsored by New Valley University · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
40
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Retinal Detachment

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03

In context

Retinal Detachment

199 studies on the registry are indexed under Retinal Detachment; 29 are open to participants now.

This study's enrollment of 40 is below the median of 60 across 58 observational studies indexed under Retinal Detachment.

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Lead sponsor

New Valley University is the lead sponsor of 25 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Retrospective observation (analytic) study

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients with successful vitrectomy for retinal detachment.

Exclusion criteria

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
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
40 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testoptical coherence tomography,multifocal electroretinogram. VA measurment

    retinal photography

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What researchers measure

Primary outcomes

  1. 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 .

    Time frame: 6 months

  2. BCVA(best corrected visual acuity)

    Best corrected Visual acuity measurement using Snellen's Acuity Chart and will be expressed as decimal notation

    Time frame: 6 Month

  3. CMT(central macualr thikness ) um

    centeral macualr thikness mesurment using using optical chorent tomgraphgy

    Time frame: 6 month

  4. mf-ERG amplituide nV/deg2

    multifocal electroretinogram amplituide mesurement using mf-ERG machine

    Time frame: 6 month

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Study locations

1 site
  • New Vally University
    Sohag, Egypt
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2023 to primary completion in May 2023, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 28, 2023
First posted
Aug 15, 2023
StartActual
Jan 1, 2023
Primary completionActual
May 1, 2023
CompletionActual
Nov 15, 2023
Last update
Dec 12, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05993208
Lead sponsor
New Valley University
Collaborators
Assiut University
Responsible party
Asmaa Kamel Ahmed Hassan (lecture, New Valley University) — Principal investigator
First posted
Aug 15, 2023
Start date
Jan 1, 2023
Primary completion
May 1, 2023
Completion
Nov 15, 2023
Last update
Dec 12, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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