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)
• Enrollment: 30
• Location: 1
• Arm: 1
• Duration (Months): 45
• Patients Per Site Per Month: 0.7

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 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	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

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

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

	Site	City	State	Country	Postal Code
1	Kagawa University Faculty of Medicine	Miki	Kagawa	Japan	761-0793

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: Cataract; Astigmatism; Epiretinal Membrane

Study Results

No Results Posted as of Mar 7, 2018