Retinal DetachmentNCT05993208
Correlation Between OCT and mFERG Findings With VA After Vitrectomy Surgery for Retinal Detachment
An observational study of Retinal Detachment, run by New Valley University at 1 site in Egypt.
Trial summary
Correlation between optical coherence tomography and multifocal electroretinogram findings with visual acuity after vitrectomy surgery for Retinal detachment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinal Detachment
- What is being tested?
- optical coherence tomography,multifocal electroretinogram. VA measurment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 15 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Retrospective observation (analytic) study
Who may be able to join
- patients with successful vitrectomy for retinal detachment.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Optical Coherence Tomography and Multifocal Electroretinogram Findings With Visual Acuity After Vitrectomy Surgery for Retinal Detachment
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
- Conditions
- Retinal Detachment
- Being tested
- optical coherence tomography,multifocal electroretinogram. VA measurment
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optical coherence tomography,multifocal electroretinogram. VA measurmentDiagnostic test
retinal photography
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 6 months
BCVA(best corrected visual acuity)
Best corrected Visual acuity measurement using Snellen's Acuity Chart and will be expressed as decimal notation
Measured: 6 Month
CMT(central macualr thikness ) um
centeral macualr thikness mesurment using using optical chorent tomgraphgy
Measured: 6 month
mf-ERG amplituide nV/deg2
multifocal electroretinogram amplituide mesurement using mf-ERG machine
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start1 Jan 2023
- Primary completion1 May 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinal DetachmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Valley University
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Principal investigator, Asmaa Kamel Ahmed Hassan, New Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993208
- Sponsor's protocol ID
- CBOCT&MFERG&VA-VRD
- Status last verified
- Aug 2023
- First submitted
- 28 Jul 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hassan A, Abdel-Radi M, Aly MOM, Alattar S. Correlation between multifocal electroretinogram and optical coherence tomography findings with visual acuity after vitrectomy surgery for retinal detachment: an observational study. Int J Retina Vitreous. 2024 Jan 23;10(1):10. doi: 10.1186/s40942-024-00527-7.
PubMed 38263142
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Optical Coherence Tomography and Multifocal Electroretinogram Findings With Visual Acuity After Vitrectomy Surgery for Retinal Detachment
- ClinicalTrials.gov ID
- NCT05993208
- Acronym / sponsor ID
- CBOCT&MFERG&VA-VRD
- Conditions
- Retinal Detachment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- New Valley UniversityUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Correlation between optical coherence tomography and multifocal electroretinogram findings with visual acuity after vitrectomy surgery for Retinal detachment.
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
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Retrospective observation (analytic) study
Key inclusion criteria (1 listed)
- patients with successful vitrectomy for retinal detachment.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| optical coherence tomography,multifocal electroretinogram. VA measurmentretinal photography | Diagnostic test | – |
Primary outcome
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 .
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
CMT(central macualr thikness ) um
Time frame: 6 month
centeral macualr thikness mesurment using using optical chorent tomgraphgy
mf-ERG amplituide nV/deg2
Time frame: 6 month
multifocal electroretinogram amplituide mesurement using mf-ERG machine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Derived from this study: PubMed 38263142Hassan A, Abdel-Radi M, Aly MOM, Alattar S. Correlation between multifocal electroretinogram and optical coherence tomography findings with visual acuity after vitrectomy surgery for retinal detachment: an observational study. Int J Retina Vitreous. 2024 Jan 23;10(1):10. doi: 10.1186/s40942-024-00527-7.
- Individual participant dataSharing planned: Undecided
Related trials for Retinal Detachment
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RecruitingObservational study
Surgical Procedure Efficiency Evaluation stuDy
Cataract, Vitreous Hemorrhage
RecruitingPhase 3
Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
Rhegmatogenous Retinal Detachment
Recruiting
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Stickler Syndrome Type 1, Stickler Syndrome Type 2
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
Macular Holes, Epiretinal Membrane
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Detachment, run by New Valley University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CMT,BCVAand mf-ERG were recoreded in 40 eyes of 40 patintes with vitrectomy for retinal detchament surgery . (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05993208, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.