Combined 25-gauge Vitrectomy and Cataract Surgery With Toric Intraocular Lens With Idiopathic Epiretinal Membrane.

Not Applicable

• Conditions: Epiretinal Membrane; Cataract; Corneal Astigmatism
• Interventions: Device: Vitrectomy with cataract surgery and toric IOL; Device: Vitrectomy with cataract surgery and common IOL

• Registration Number: NCT02328157
• Lead Sponsor: Kagawa University

Brief Summary

Toric intraocular lens (IOL) is now widely used for the cataract surgery with preoperative corneal astigmatism.

Symptomatic epiretinal membrane (ERM) is often treated with 25-gauge transconjunctival sutureless vitrectomy, resulting in good visual recovery. So far, however, limited information is available on the the stability of axis rotation, astigmatism correction, and improvement in uncorrected distance visual acuity, using astigmatism-correcting IOL in a 25-gauge transconjunctival sutureless vitrectomy combined with cataract surgery. In the current study, eyes with a preoperative corneal cylinder of more than 0.75 diopter had a triple procedure for idiopathic ERM using a toric IOL. Outcome measures will be the amount of IOL axis rotation, uncorrected visual acuity, corrected distance visual acuity, and corneal and refractive astigmatism up to 6 months postoperatively. We are expecting to show that postoperative IOL axis stability is similar to that reported for cataract surgery alone in vitrectomy (triple procedure) for idiopathic ERM with a toric IOL.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-13
• Study First Submitted QC: 2014-12-26
• Study First Posted: 2014-12-31
• Study Start: 2015-01
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-06
• Last Update Posted: 2018-03-07
• Primary Completion: 2018-10
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Preoperative corneal cylinder of more than 0.75 diopter
• Symptomatic idiopathic epiretinal membrane
• Symptomatic cataract

Exclusion Criteria

• Severe media opacity other cataract
• Eyes with other retinal disease, such as diabetic retinopathy, retinal vein occlusion, rhegmatogenous retinal detachment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cataract with ERM and astigmatism	Vitrectomy with cataract surgery and toric IOL	Eyes that have cataract and ERM with a preoperative corneal cylinder of more than 0.75 diopter.
Cataract with ERM and astigmatism	Vitrectomy with cataract surgery and common IOL	Eyes that have cataract and ERM with a preoperative corneal cylinder of more than 0.75 diopter.

Primary Outcome Measures

Name	Time	Method
The degree of IOL axis rotation from the end of surgery	Six months after the inplantation

Trial Locations

Locations (1)

Kagawa University Faculty of Medicine; 🇯🇵 Miki, Kagawa, Japan