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

Cataract Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02183831
• Other study ID #: 1-2014-0010
• Status: Completed
• Phase: N/A
• First received: June 23, 2014
• Last updated: July 2, 2014
• Start date: May 2014
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 79 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Insertion of the capsular tension ring

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No