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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02328157
• Other study ID #: H26-061
• Status: Active, not recruiting
• Phase: N/A
• First received: December 13, 2014
• Last updated: March 6, 2018
• Start date: January 2015
• Est. completion date: October 2018

Study information

• Verified date: March 2018
• Source: Kagawa University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Astigmatism
• Cataract
• Corneal Astigmatism
• Epiretinal Membrane

Intervention

Device:
• Vitrectomy with cataract surgery and toric IOL

• Vitrectomy with cataract surgery and common IOL

Locations

Country	Name	City	State
Japan	Kagawa University Faculty of Medicine	Miki	Kagawa

Sponsors (1)

Lead Sponsor	Collaborator
Kagawa University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The degree of IOL axis rotation from the end of surgery		Six months after the inplantation