"Cataract Surgery in Eyes With Epiretinal Membrane"

Cataract Clinical Trial

Official title:

"Retinal Thickness Change Following Cataract Surgery in Eyes With Epiretinal Membrane"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03404323
• Other study ID #: 15062015
• Status: Completed
• Phase: N/A
• First received: January 11, 2018
• Last updated: January 18, 2018
• Start date: July 1, 2015
• Est. completion date: May 1, 2017

Study information

• Verified date: January 2018
• Source: St John of God Hospital, Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 1, 2017
• Est. primary completion date: July 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Epiretinal Membrane
• Irvine-Gass Syndrome
• Macular Edema
• Pseudophakic Cystoid Macular Edema

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
St John of God Hospital, Vienna

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	central macular thickness	Central 1-millimeter and 3-milimeter retinal thickness	Change from Baseline central macular thickness at 3 months