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Completed

NCT Number: NCT02183831

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

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

40 year–79 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Insertion of the capsular tension ring

Device

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 8, 2014
Registry last updated
Jul 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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