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

NCT ID: NCT02328157

Last Updated: 2018-03-07

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2018-10-31

Brief Summary

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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

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Conditions

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Cataract Epiretinal Membrane Corneal Astigmatism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cataract with ERM and astigmatism

Eyes that have cataract and ERM with a preoperative corneal cylinder of more than 0.75 diopter.

Group Type EXPERIMENTAL

Vitrectomy with cataract surgery and toric IOL

Intervention Type DEVICE

Vitrectomy with cataract surgery and common IOL

Intervention Type DEVICE

Interventions

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Vitrectomy with cataract surgery and toric IOL

Intervention Type DEVICE

Vitrectomy with cataract surgery and common IOL

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kagawa University

OTHER

Sponsor Role lead

Responsible Party

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Akitaka Tsujikawa

Professor and Chairman

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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AKITAKA TSUJIKAWA, MD

Role: PRINCIPAL_INVESTIGATOR

Kagawa Univerisity Faculty of Medicine

Locations

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Kagawa University Faculty of Medicine

Hiragi, Kagawa-ken, Japan

Site Status

Countries

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Japan

Other Identifiers

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H26-061

Identifier Type: -

Identifier Source: org_study_id

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