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

NCT02328157 | Unknown

• 1 other identifier: H26-061
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract; Epiretinal Membrane; Corneal Astigmatism

Outcome Measures

Primary Outcomes (1)

• The degree of IOL axis rotation from the end of surgery

  Six months after the inplantation

Study Arms (1)

Cataract with ERM and astigmatism

EXPERIMENTAL

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

Interventions

Vitrectomy with cataract surgery and toric IOL DEVICE

Cataract with ERM and astigmatism

Vitrectomy with cataract surgery and common IOL DEVICE

Cataract with ERM and astigmatism

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Preoperative corneal cylinder of more than 0.75 diopter
• Symptomatic idiopathic epiretinal membrane
• Symptomatic cataract

You may not qualify if:

• Severe media opacity other cataract
• Eyes with other retinal disease, such as diabetic retinopathy, retinal vein occlusion, rhegmatogenous retinal detachment

Sponsors & Collaborators

• Kagawa University: lead

Study Sites (1)

Kagawa University Faculty of Medicine

Hiragi, Kagawa-ken, 761-0793, Japan

Location

MeSH Terms

Conditions

Cataract; Epiretinal Membrane; Astigmatism

Interventions

Vitrectomy; Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Retinal Diseases; Refractive Errors

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Refractive Surgical Procedures

Study Officials

• AKITAKA TSUJIKAWA, MD

  Kagawa Univerisity Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman

Study Record Dates

• First Submitted: December 13, 2014
• First Posted: December 31, 2014
• Study Start: January 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: March 7, 2018

Record last verified: 2018-03

Locations

JP (1)