Comparison of Clinical Outcomes After Cataract Surgery With and Without Capsular Tension Ring

This study was set up to identify clinical outcomes including a refractive shift or change in IOL calculation accuracy and optical quality after Ophtec® capsular tension ring in the eyes without zonular instability.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: Insertion of the capsular tension ring

• Study Type: Observational
• Enrollment (Actual): 52

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The patients who were planned to undergo the cataract surgery in Department of Ophthalmology, Yonsei University College of Medicine

Description

Inclusion Criteria:

1. age between 40 and 79 years
2. no history of eye surgery or glaucoma
3. a transparent central cornea
4. pupil dilation at the preoperative examination of at least 6.0 mm
5. absence of biomicroscopic signs of pseudoexfoliation
6. normal fundus examination

Exclusion Criteria:

1. presence of ocular disease that might affect the visual outcome (e.g., color vision disturbance, chronic uveitis)
2. presence of ocular disease that might affect contrast sensitivity function (e.g., glaucoma, maculopathy, high myopia)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Capsular tension ring non insertion group; The patients who had same cataract surgery procedure without CTR insertion
Capsular tension ring insertion group; The patients who underwent capsular tension ring insertion just before IOL implantation during cataract surgery	Device: Insertion of the capsular tension ring; Other Names: a pre-loaded CTR in single use injector was inserted just before IOL implantation during cataract surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best corrected visual acuity	Visual acuity measurement using refractive error correction	1 month after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
refractive error	Autokeratometry (KR-7100; Topcon, Tokyo, Japan) and manifested refraction were performed to examine refractive errors	1 month after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
Anterior chamber depth	obtained with a Scheimpflug imaging system (Pentacam; OCULUS Optikgeräte GmbH, Wetzlar, Germany)	3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
Ocular aberrations	measured using the ray-tracing aberrometer (iTrace, Tracey Technologies, Houston, TX, USA) at a pupil size of 5 mm in mesopic conditions, without pharmacologic dilatation	1month after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
constrast sensitivity	measured at five spatial frequencies (1.5, 3, 6, 12, and 18 Hz) using the Optec 6500 vision testing system	3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
posterior capsular opacity grades	graded after dilation of pupil over 6 mm, based on slit lamp examination findings	3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
Best corrected visual acuity	Visual acuity measurement using refractive error correction	3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
refractive error	Autokeratometry (KR-7100; Topcon, Tokyo, Japan) and manifested refraction were performed to examine refractive errors	3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
Ocular aberrations	measured using the ray-tracing aberrometer (iTrace, Tracey Technologies, Houston, TX, USA) at a pupil size of 5 mm in mesopic conditions, without pharmacologic dilatation	3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: June 23, 2014
• First Submitted That Met QC Criteria: July 2, 2014
• First Posted (Estimate): July 8, 2014

Study Record Updates

• Last Update Posted (Estimate): July 8, 2014
• Last Update Submitted That Met QC Criteria: July 2, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 1-2014-0010