"Cataract Surgery in Eyes With Epiretinal Membrane"

NCT ID: NCT03404323

Last Updated: 2018-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-01

Study Completion Date

2017-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is to evaluate retinal thickness change and the occurrence of central structural retinal changes after uneventful small-incision cataract surgery in eyes with asymptomatic early stages of epiretinal membrane.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Optical coherence tomography (OCT) is nowadays used in daily clinical practice and has become a helpful tool for detection of macular changes also in presence of opacification of the lens before cataract surgery. Using recent high-resolution OCT technology, early stages of epiretinal membranes can easily be detected and analysed. Since cataract surgery is one of the most frequently performed operations worldwide, this study was aimed to investigate the influence of uncomplicated cataract surgery on central retinal thickness and the incidence of structural and morphological macular changes after surgery in eyes with asymptomatic epiretinal membrane.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Epiretinal Membrane Pseudophakic Cystoid Macular Edema Irvine-Gass Syndrome Cataract

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* visually compromising cataract and asymptomatic early stages of epiretinal membrane with no structural changes such as cysts or photoreceptor distribution in optical coherence tomography.

Exclusion Criteria

* visual impairment or metamorphopsia due to epiretinal membrane
* history of branch retinal vein occlusion
* central retinal vein occlusion
* wet or dry macular degeneration
* diabetic retinopathy
* uveitis or other inflammatory eye disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

St John of God Hospital, Vienna

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Barbara Wetzel

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Barbara Wetzel, MD

Role: PRINCIPAL_INVESTIGATOR

St John of God Hospital, Vienna

Georgios Mylonas, MD

Role: STUDY_DIRECTOR

St John of God Hospital, Vienna

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

15062015

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.