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

Yonsei University52 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Cataract

Interventions

Insertion of the capsular tension ringDEVICE

Eligibility

Sex: ALLMin age: 40 YearsMax age: 79 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Best corrected visual acuity

Visual acuity measurement using refractive error correction

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 1month after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring

Secondary Outcomes

constrast sensitivity

measured at five spatial frequencies (1.5, 3, 6, 12, and 18 Hz) using the Optec 6500 vision testing system

Time frame: 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

Time frame: 3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring

Data from ClinicalTrials.gov

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