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CompletedNCT02183831Updated Jul 8, 2014

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

An observational study in Cataract, sponsored by Yonsei University. Completed. Open to participants aged 40 Years to 79 Years. Per ClinicalTrials.gov, last updated 2014-07-08.

Sponsored by Yonsei University · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
52
Ages
40 Years to 79 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cataract

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03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 52 is below the median of 81 across 484 observational studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 79 Years
Sexes eligible
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

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

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)
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
52 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • DeviceInsertion of the capsular tension ring

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

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  1. 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

  2. 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

  3. Best corrected visual acuity

    Visual acuity measurement using refractive error correction

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

  4. refractive error

    Autokeratometry (KR-7100; Topcon, Tokyo, Japan) and manifested refraction were performed to examine refractive errors

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

  5. 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: 3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02183831
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Jul 8, 2014
Start date
May 2014
Primary completion
Jun 2014
Completion
Jun 2014
Last update
Jul 8, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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