Macular DystrophyNCT07171541
Correlation Between OCT and Mf-ERG Findings With BCVA in Patients With Macular Dystrophy
An observational study of Macular Dystrophy, run by New Valley University.
Trial summary
Correlation between optical coherence tomography and multifocal electroretinogram findings with visual acuity in patients with macular dystrophy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Macular Dystrophy
- What is being tested?
- OCT ,mFERG,VA test
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2025to 20 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All patients diagnosed with macular dystrophy during the period of the study
Who may be able to join
- All patients diagnosed with macular dystrophy in Tiba Eye Centre, Egypt, Assiut, during the period of the study
Who cannot join
- The patients diagnosed with macular dystrophy refuse to contribute to the study.
About this study
Official title: Correlation Between Optical Coherence Tomography and Multifocal Electroretinogram Findings With Visual Acuity in Patients With Macular Dystrophy
Correlation between optical coherence tomography and multifocal electroretinogram findings with visual acuity in patients with macular dystrophy.
Read the detailed description
Macular dystrophies cause progressive central vision loss, but the relationship between structural retinal changes (OCT) and functional deficits (mf-ERG) with visual outcomes remains poorly understood. Current clinical assessment relies primarily on visual acuity, which inadequately reflects retinal damage or predicts disease progression. This knowledge gap limits prognostic accuracy and optimal patient management. Recent advances in OCT and mf-ERG technology provide an opportunity to establish robust structure-function correlations. Understanding these relationships will enhance patient care through improved prognosis, standardized monitoring protocols, and better clinical trial outcome measures for macular dystrophy patients.
- Conditions
- Macular Dystrophy
- Being tested
- OCT ,mFERG,VA test
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT ,mFERG,VA testDiagnostic test
retinal photography by OCT, VA measurement, and mfERG test
What is being measured
The primary outcome is the main question the study is designed to answer.
BCVA (best corrected visual acuity)
BCVA was recorded in 30 eyes of 30 patients with macular dystrophy.
Measured: Day 1/month 3
CMT (central macular thickness) μm Central macular thickness measurement using optical coherence tomography
CMT (central macular thickness) in μm in 30 eyes of 30 patients with macular dystrophy Central macular thickness measurement using optical coherence tomography.
Measured: Day1/month 3
mf-ERG amplituide nV/deg2
mf-ERG amplitude nV/deg² in 30 eyes of 30 patients with macular dystrophy multifocal electroretinogram amplitude measurement using the mf-ERG machine
Measured: Day 1/month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start20 Sep 2025 (estimated)
- Primary completion20 Nov 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DystrophyStudies 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
- Prospective
- Enrolment
- 30 participants (estimated)
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
- NCT07171541
- Sponsor's protocol ID
- CBOTMEFVAPMD
- Status last verified
- Sep 2025
- First submitted
- 27 Aug 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. 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 in Patients With Macular Dystrophy
- ClinicalTrials.gov ID
- NCT07171541
- Acronym / sponsor ID
- CBOTMEFVAPMD
- Conditions
- Macular Dystrophy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- New Valley UniversityUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- 20 Sep 2025 (estimated)
- Primary completion
- 20 Nov 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 12 Sep 2025 (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 in patients with macular dystrophy.
Detailed description
Macular dystrophies cause progressive central vision loss, but the relationship between structural retinal changes (OCT) and functional deficits (mf-ERG) with visual outcomes remains poorly understood. Current clinical assessment relies primarily on visual acuity, which inadequately reflects retinal damage or predicts disease progression. This knowledge gap limits prognostic accuracy and optimal patient management. Recent advances in OCT and mf-ERG technology provide an opportunity to establish robust structure-function correlations. Understanding these relationships will enhance patient care through improved prognosis, standardized monitoring protocols, and better clinical trial outcome measures for macular dystrophy patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients diagnosed with macular dystrophy during the period of the study
Key inclusion criteria (1 listed)
- All patients diagnosed with macular dystrophy in Tiba Eye Centre, Egypt, Assiut, during the period of the study
Key exclusion criteria (1 listed)
- The patients diagnosed with macular dystrophy refuse to contribute to the study.
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 |
|---|---|---|
| OCT ,mFERG,VA testretinal photography by OCT, VA measurement, and mfERG test | Diagnostic test | – |
Primary outcome
BCVA (best corrected visual acuity)
Time frame: Day 1/month 3
BCVA was recorded in 30 eyes of 30 patients with macular dystrophy.
CMT (central macular thickness) μm Central macular thickness measurement using optical coherence tomography
Time frame: Day1/month 3
CMT (central macular thickness) in μm in 30 eyes of 30 patients with macular dystrophy Central macular thickness measurement using optical coherence tomography.
mf-ERG amplituide nV/deg2
Time frame: Day 1/month 6
mf-ERG amplitude nV/deg² in 30 eyes of 30 patients with macular dystrophy multifocal electroretinogram amplitude measurement using the mf-ERG machine
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Macular Dystrophy, run by New Valley University.
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 1 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: opening soon, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
BCVA (best corrected visual acuity) (time frame: Day 1/month 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2025.