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Clinical Trials/NCT02328157
NCT02328157
Unknown
Not Applicable

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

Kagawa University1 site in 1 country30 target enrollmentJanuary 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cataract
Sponsor
Kagawa University
Enrollment
30
Locations
1
Primary Endpoint
The degree of IOL axis rotation from the end of surgery
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
October 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Akitaka Tsujikawa

Professor and Chairman

Kagawa University

Eligibility Criteria

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

Outcomes

Primary Outcomes

The degree of IOL axis rotation from the end of surgery

Time Frame: Six months after the inplantation

Study Sites (1)

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