Epiretinal MembraneNCT06800638
Comprehensive Review of Retinal Pseudo-Holes: Clinical Presentation, Diagnosis, Pathophysiology, and Management
An observational study of Epiretinal Membrane and Age-related Disease, run by Mohammad Reza Tokhmehchi at 1 site in Iran.
Trial summary
Retinal pseudo-holes (RPH) are macular abnormalities that mimic macular holes (MH) but lack full-thickness retinal disruption. This systematic review, based on 35 studies, explores their clinical presentation, diagnosis, pathophysiology, and management. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Epiretinal Membrane, Age-related Disease, Idiopathic ERM
- How many people
- 10 participants
- Where
- 1 siteIran
- Study dates
- 1 Jun 2024to 25 Sep 2024
- 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: 35
Who may be able to join
- Studies that directly addressed retinal pseudo-holes, their clinical presentation, diagnostic modalities, pathophysiology, or treatment.
- Peer-reviewed clinical trials, case reports, observational studies, and reviews.
- Studies that utilized OCT or other imaging techniques (such as fluorescein angiography or fundus photography) to diagnose retinal pseudo-holes.
- Studies that were published in English and provided full-text access.
Who cannot join
- Studies that did not specifically focus on retinal pseudo-holes but instead dealt with other retinal conditions (e.g., full-thickness macular holes, retinal detachment).
- Studies that were not peer-reviewed (e.g., conference abstracts, opinion pieces).
- Non-English language studies or those without available full texts.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Presentation, Diagnostic Approaches, Pathophysiology, and Management of Retinal Pseudo-Holes: a Comprehensive Synthesis of 35 Peer-Reviewed Studies
Retinal pseudo-holes (RPH) are macular abnormalities that mimic macular holes (MH) but lack full-thickness retinal disruption. This systematic review, based on 35 studies, explores their clinical presentation, diagnosis, pathophysiology, and management.
Diagnosis: Differentiating RPH from MH is challenging due to overlapping symptoms such as central scotomas and visual distortion. Optical coherence tomography (OCT) has become the gold standard for diagnosis, surpassing older imaging techniques like fundus photography and fluorescein angiography. OCT provides detailed, non-invasive imaging that helps identify RPH's hallmark feature: a foveal depression without retinal break.
Read more
Pathophysiology: RPH is primarily caused by mechanical forces exerted on the macula by epiretinal membranes (ERM) and vitreomacular traction (VMT). These forces distort the retina, creating a pseudo-hole. Risk factors include aging, high myopia, trauma, and diabetes.
Management: Many RPH cases are managed conservatively with regular monitoring, as the condition often remains stable. Surgical intervention, such as pars plana vitrectomy (PPV) with membrane peeling, is reserved for symptomatic cases with significant visual impairment. Surgery has shown promising outcomes, with most patients experiencing improved visual acuity.
Research Needs: Further studies are needed to explore the long-term outcomes of RPH, identify factors predicting progression to MH, and assess the utility of advanced imaging techniques like OCT angiography in improving diagnosis and monitoring.
This review underscores the importance of accurate differentiation between RPH and MH to ensure appropriate management and avoid unnecessary treatments.
Read the detailed description
This is a REVIEW study on Retinal pseudo-holes.
- Conditions
- Epiretinal Membrane, Age-related Disease, Idiopathic ERM
- Medical subject headings
- Epiretinal Membrane
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal Thickness
Measuring retinal thickness using Optical Coherence Tomography (OCT) to assess structural changes associated with the severity of the epiretinal membrane. Unit of Measure: Micrometers (µm)
Measured: up to 12 weeks
Secondary outcomes (1)
Visual Acuity
Evaluating patients' visual acuity using the LogMAR scale to determine the functional impact of the epiretinal membrane on vision. Unit of Measure: LogMAR (logarithm of the minimum angle of resolution)
Measured: up to 10weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start1 Jun 2024
- Primary completion20 Aug 2024
- Study completion25 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epiretinal MembraneStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohammad Reza Tokhmehchi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohammad Reza Tokhmehchi, Hamadan University of Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800638
- Sponsor's protocol ID
- IR.GUMS.REC.1400.134
- Status last verified
- Jan 2025
- First submitted
- 12 Jan 2025
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Presentation, Diagnostic Approaches, Pathophysiology, and Management of Retinal Pseudo-Holes: a Comprehensive Synthesis of 35 Peer-Reviewed Studies
- ClinicalTrials.gov ID
- NCT06800638
- Acronym / sponsor ID
- IR.GUMS.REC.1400.134
- Conditions
- Epiretinal Membrane, Age-related Disease, Idiopathic ERM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mohammad Reza TokhmehchiUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 30 Jan 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.
Retinal pseudo-holes (RPH) are macular abnormalities that mimic macular holes (MH) but lack full-thickness retinal disruption. This systematic review, based on 35 studies, explores their clinical presentation, diagnosis, pathophysiology, and management.
Diagnosis: Differentiating RPH from MH is challenging due to overlapping symptoms such as central scotomas and visual distortion. Optical coherence tomography (OCT) has become the gold standard for diagnosis, surpassing older imaging techniques like fundus photography and fluorescein angiography. OCT provides detailed, non-invasive imaging that helps identify RPH's hallmark feature: a foveal depression without retinal break.
Pathophysiology: RPH is primarily caused by mechanical forces exerted on the macula by epiretinal membranes (ERM) and vitreomacular traction (VMT). These forces distort the retina, creating a pseudo-hole. Risk factors include aging, high myopia, trauma, and diabetes.
Management: Many RPH cases are managed conservatively with regular monitoring, as the condition often remains stable. Surgical intervention, such as pars plana vitrectomy (PPV) with membrane peeling, is reserved for symptomatic cases with significant visual impairment. Surgery has shown promising outcomes, with most patients experiencing improved visual acuity.
Research Needs: Further studies are needed to explore the long-term outcomes of RPH, identify factors predicting progression to MH, and assess the utility of advanced imaging techniques like OCT angiography in improving diagnosis and monitoring.
This review underscores the importance of accurate differentiation between RPH and MH to ensure appropriate management and avoid unnecessary treatments.
Detailed description
This is a REVIEW study on Retinal pseudo-holes.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 35
Key inclusion criteria (4 listed)
- Studies that directly addressed retinal pseudo-holes, their clinical presentation, diagnostic modalities, pathophysiology, or treatment.
- Peer-reviewed clinical trials, case reports, observational studies, and reviews.
- Studies that utilized OCT or other imaging techniques (such as fluorescein angiography or fundus photography) to diagnose retinal pseudo-holes.
- Studies that were published in English and provided full-text access.
Key exclusion criteria (3 listed)
- Studies that did not specifically focus on retinal pseudo-holes but instead dealt with other retinal conditions (e.g., full-thickness macular holes, retinal detachment).
- Studies that were not peer-reviewed (e.g., conference abstracts, opinion pieces).
- Non-English language studies or those without available full texts.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retinal Thickness
Time frame: up to 12 weeks
Measuring retinal thickness using Optical Coherence Tomography (OCT) to assess structural changes associated with the severity of the epiretinal membrane. Unit of Measure: Micrometers (µm)
1 secondary outcome
Visual Acuity
Time frame: up to 10weeks
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 30 Jan 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. 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 Epiretinal Membrane and Age-related Disease, run by Mohammad Reza Tokhmehchi at 1 site in Iran.
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 4 inclusion and 3 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 30 Jan 2025. 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 Iran. 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?
Retinal Thickness (time frame: up to 12 weeks). 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 30 Jan 2025.