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

Sponsor
Kagawa University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02328157
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
45
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Vitrectomy with cataract surgery and toric IOL
  • Device: Vitrectomy with cataract surgery and common IOL
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Jan 1, 2015
Anticipated Primary Completion Date :
Oct 1, 2018
Anticipated Study Completion Date :
Oct 1, 2018

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. The degree of IOL axis rotation from the end of surgery [Six months after the inplantation]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Kagawa University Faculty of MedicineMikiKagawaJapan761-0793

Sponsors and Collaborators

  • Kagawa University

Investigators

  • Principal Investigator: AKITAKA TSUJIKAWA, MD, Kagawa Univerisity Faculty of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Akitaka Tsujikawa, Professor and Chairman, Kagawa University
ClinicalTrials.gov Identifier:
NCT02328157
Other Study ID Numbers:
  • H26-061
First Posted:
Dec 31, 2014
Last Update Posted:
Mar 7, 2018
Last Verified:
Mar 1, 2018
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 7, 2018