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

Study Overview
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Brief Summary
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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.

Conditions
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Cataract

Intervention / Treatment
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* Device: Insertion of the capsular tension ring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 40 and 79 years no history of eye surgery or glaucoma a transparent central cornea pupil dilation at the preoperative examination of at least 6.0 mm absence of biomicroscopic signs of pseudoexfoliation normal fundus examination Exclusion Criteria: presence of ocular disease that might affect the visual outcome (e.g., color vision disturbance, chronic uveitis) presence of ocular disease that might affect contrast sensitivity function (e.g., glaucoma, maculopathy, high myopia)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 |