NCT05171621

Brief Summary

Assessing metamorphopsia and quality of vision pre and post epiretinal and macular hole surgery

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

Typical duration 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

October 16, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 29, 2021

Completed
Last Updated

December 29, 2021

Status Verified

December 1, 2021

Enrollment Period

2 years

First QC Date

November 25, 2021

Last Update Submit

December 10, 2021

Conditions

Ophthalmologic ComplicationEpiretinal MembraneMetamorphopsiaMacular Holes

Outcome Measures

Primary Outcomes (1)

  • Compare the responses of the McAllinden and Metamorphopsia Questionnaire

    analysing changes to responses in the 2 questionnaires pre and post surgery

    pre surgery and 2 - 3 months post surgery

Secondary Outcomes (1)

  • Changes to BCVA score

    Pre surgery and 2-3 months post surgery

Other Outcomes (1)

  • Assess correlations between the Mcallinden and Metamorphopsia questionnaire scores and objective clinical parameters

    Pre surgery and 2-3 month post surgery

Study Arms (2)

Macular holes

Epiretinal membranes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have epiretinal membranes or macular holes and have been listed for a vitrectomy

You may qualify if:

  • Participant is willing and able to give informed consent
  • \>18 years old
  • Patients listed for epi retinal and macular hole surgery
  • Patient is able to perform study procedures

You may not qualify if:

  • Patients who are diagnosed with a condition other than epiretinal membrane or macular hole
  • Patients not undergoing epiretinal or macular hole surgery
  • Patients will be excluded if there are any complications within surgery, or undergo any procedures that is not an epiretinal or macular hole surgery (i.e vitrectomy, phacoemulsification (lens extraction) as this can affect visual outcomes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Wales

Cardiff, cf14 4xw, United Kingdom

Location

MeSH Terms

Conditions

Epiretinal MembraneVision DisordersRetinal Perforations

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Clinical Research Officer

Study Record Dates

First Submitted

November 25, 2021

First Posted

December 29, 2021

Study Start

October 16, 2019

Primary Completion

October 31, 2021

Study Completion

October 31, 2021

Last Updated

December 29, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)