- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06800638
Comprehensive Review of Retinal Pseudo-Holes: Clinical Presentation, Diagnosis, Pathophysiology, and Management
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.
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Hamadan, Iran, Islamic Republic of
- Hamadan University of Medical Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
up to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Acuity
Time Frame: up to 10weeks
|
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)
|
up to 10weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IR.GUMS.REC.1400.134
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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