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

NCT02183831 | Completed

• 1 other identifier: 1-2014-0010
• Study Type: observational
• Target: 52
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• constrast sensitivity

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

• posterior capsular opacity grades

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

• Best corrected visual acuity

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

• refractive error

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

• Ocular aberrations

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

Study Arms (2)

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

Insertion of the capsular tension ring DEVICE

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

Capsular tension ring insertion group

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yonsei University: lead

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2014
• First Posted: July 8, 2014
• Study Start: May 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 8, 2014

Record last verified: 2014-06