NCT06800638

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 30, 2025

Completed
Last Updated

January 30, 2025

Status Verified

January 1, 2025

Enrollment Period

3 months

First QC Date

January 12, 2025

Last Update Submit

January 28, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    up to 12 weeks

Secondary Outcomes (1)

  • Visual Acuity

    up to 10weeks

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

35

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamadan University of Medical Sciences

Hamadan, Iran

Location

MeSH Terms

Conditions

Epiretinal Membrane

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

January 12, 2025

First Posted

January 30, 2025

Study Start

June 1, 2024

Primary Completion

August 20, 2024

Study Completion

September 25, 2024

Last Updated

January 30, 2025

Record last verified: 2025-01

Locations