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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02183831
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief 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.

Condition or disease Intervention/treatment
Cataract Device: Insertion of the capsular tension ring

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Study Type : Observational
Actual Enrollment : 52 participants
Observational Model: Case Control
Time Perspective: Retrospective
Study Start Date : May 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

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 Name: a pre-loaded CTR in single use injector was inserted just before IOL implantation during cataract surgery




Primary Outcome Measures :
  1. Best corrected visual acuity [ Time Frame: 1 month after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring ]
    Visual acuity measurement using refractive error correction

  2. refractive error [ Time Frame: 1 month after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring ]
    Autokeratometry (KR-7100; Topcon, Tokyo, Japan) and manifested refraction were performed to examine refractive errors

  3. Anterior chamber depth [ Time Frame: 3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring ]
    obtained with a Scheimpflug imaging system (Pentacam; OCULUS Optikgeräte GmbH, Wetzlar, Germany)

  4. Ocular aberrations [ Time Frame: 1month after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring ]
    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


Secondary Outcome Measures :
  1. constrast sensitivity [ Time Frame: 3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring ]
    measured at five spatial frequencies (1.5, 3, 6, 12, and 18 Hz) using the Optec 6500 vision testing system

  2. posterior capsular opacity grades [ Time Frame: 3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring ]
    graded after dilation of pupil over 6 mm, based on slit lamp examination findings

  3. Best corrected visual acuity [ Time Frame: 3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring ]
    Visual acuity measurement using refractive error correction

  4. refractive error [ Time Frame: 3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring ]
    Autokeratometry (KR-7100; Topcon, Tokyo, Japan) and manifested refraction were performed to examine refractive errors

  5. Ocular aberrations [ Time Frame: 3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring ]
    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



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Ages Eligible for Study:   40 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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)

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02183831    
Other Study ID Numbers: 1-2014-0010
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases