NCT03661593

Brief Summary

Examination of aniseikonia in epiretinal membranes patients before and after surgery

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 7, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

September 7, 2018

Status Verified

September 1, 2018

Enrollment Period

1.2 years

First QC Date

August 31, 2018

Last Update Submit

September 5, 2018

Conditions

Epiretinal Membrane

Outcome Measures

Primary Outcomes (1)

  • Aniseikonia

    Measure amount of aniseikonia by measuring aniseikonia with both computer program aniseikonia inspector and the New Aniseikonia test

    1 year

Study Arms (2)

Cataract guideline

EXPERIMENTAL

In this patients we follow cataract guideline and correct the patients ametropia during the cataract surgery

Other: Cataract guideline

Standard refraction

NO INTERVENTION

The patients gets an IOL ensuring his preoperatively refraction

Interventions

Cataract guidelineOTHER

The patients gets an IOL according to cataract guideline correcting the ametropia

Cataract guideline

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Epiretinal membrane Phakic on both eyes

You may not qualify if:

  • no previous eye surgeries
  • refractive status +/- 2 seq

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye department, Nordre ringvej 56

Copenhagen, Glostrup, 2600, Denmark

RECRUITING

MeSH Terms

Conditions

Epiretinal Membrane

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Masking done by a third person following computer randomization
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 31, 2018

First Posted

September 7, 2018

Study Start

November 1, 2017

Primary Completion

January 1, 2019

Study Completion

November 1, 2019

Last Updated

September 7, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

No planing on sharing

Locations

DK(1)