Back to resultsCombined 25-gauge Vitrectomy and Cataract Surgery With Toric Intraocular Lens With Idiopathic Epiretinal Membrane.
Primary Purpose
Cataract, Epiretinal Membrane, Corneal Astigmatism
Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Vitrectomy with cataract surgery and toric IOL
Vitrectomy with cataract surgery and common IOL
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
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
Sites / Locations
- Kagawa University Faculty of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cataract with ERM and astigmatism
Arm Description
Eyes that have cataract and ERM with a preoperative corneal cylinder of more than 0.75 diopter.
Outcomes
Primary Outcome Measures
The degree of IOL axis rotation from the end of surgery
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02328157
Brief Title
Combined 25-gauge Vitrectomy and Cataract Surgery With Toric Intraocular Lens With Idiopathic Epiretinal Membrane.
Official Title
Combined 25-gauge Vitrectomy and Cataract Surgery With Toric Intraocular Lens With Idiopathic Epiretinal Membrane.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
October 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kagawa University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Epiretinal Membrane, Corneal Astigmatism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cataract with ERM and astigmatism
Arm Type
Experimental
Arm Description
Eyes that have cataract and ERM with a preoperative corneal cylinder of more than 0.75 diopter.
Intervention Type
Device
Intervention Name(s)
Vitrectomy with cataract surgery and toric IOL
Intervention Type
Device
Intervention Name(s)
Vitrectomy with cataract surgery and common IOL
Primary Outcome Measure Information:
Title
The degree of IOL axis rotation from the end of surgery
Time Frame
Six months after the inplantation
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AKITAKA TSUJIKAWA, MD
Organizational Affiliation
Kagawa Univerisity Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kagawa University Faculty of Medicine
City
Miki
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Combined 25-gauge Vitrectomy and Cataract Surgery With Toric Intraocular Lens With Idiopathic Epiretinal Membrane.
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