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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
Sponsor:
Information provided by (Responsible Party):
Akitaka Tsujikawa, 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.


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. The degree of IOL axis rotation from the end of surgery [ Time Frame: Six months after the inplantation ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328157


Locations
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Japan
Kagawa University Faculty of Medicine
Miki, Kagawa, Japan, 761-0793
Sponsors and Collaborators
Kagawa University
Investigators
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Principal Investigator: AKITAKA TSUJIKAWA, MD Kagawa Univerisity Faculty of Medicine
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Responsible Party: Akitaka Tsujikawa, Professor and Chairman, Kagawa University
ClinicalTrials.gov Identifier: NCT02328157    
Other Study ID Numbers: H26-061
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Cataract
Astigmatism
Epiretinal Membrane
Lens Diseases
Eye Diseases
Refractive Errors
Retinal Diseases