Combined 25-gauge Vitrectomy and Cataract Surgery With Toric Intraocular Lens With Idiopathic Epiretinal Membrane.
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|ClinicalTrials.gov Identifier: NCT02328157|
Recruitment Status : Unknown
Verified March 2018 by Akitaka Tsujikawa, Kagawa University.
Recruitment status was: Active, not recruiting
First Posted : December 31, 2014
Last Update Posted : March 7, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Cataract Epiretinal Membrane Corneal Astigmatism||Device: Vitrectomy with cataract surgery and toric IOL Device: Vitrectomy with cataract surgery and common IOL||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Combined 25-gauge Vitrectomy and Cataract Surgery With Toric Intraocular Lens With Idiopathic Epiretinal Membrane.|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2018|
Experimental: Cataract with ERM and astigmatism
Eyes that have cataract and ERM with a preoperative corneal cylinder of more than 0.75 diopter.
Device: Vitrectomy with cataract surgery and toric IOL
Device: Vitrectomy with cataract surgery and common IOL
- The degree of IOL axis rotation from the end of surgery [ Time Frame: Six months after the inplantation ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328157
|Kagawa University Faculty of Medicine|
|Miki, Kagawa, Japan, 761-0793|
|Principal Investigator:||AKITAKA TSUJIKAWA, MD||Kagawa Univerisity Faculty of Medicine|