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Comparative Study of Photopic and Mesopic Distance, Intermediate and Near Visual Acuity, and Spectacle Independence

This study has been completed.
Sponsor:
Information provided by:
Innovative Medical
ClinicalTrials.gov Identifier:
NCT01191502
First received: August 27, 2010
Last updated: October 5, 2011
Last verified: October 2011
  Purpose

The purpose of this study is to evaluate visual acuity in different lighting conditions (daylight and night time) and distances (distance, near and intermediate), and the independence of glasses, in patients who have had binocular implantation of the Tecnis Multifocal IOL or the Crystalens™ HD Accommodating IOL.


Condition
Visual Acuity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Comparative Study of Photopic and Mesopic Distance Intermediate and Near Visual Acuity, and Spectacle Independence With Binocular Implantation of the Tecnis Multifocal (TMF) Intraocular Lens or Crystalens HD (CHD) Intraocular Lens

Resource links provided by NLM:


Further study details as provided by Innovative Medical:

Primary Outcome Measures:
  • Manifest refraction (monocular) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Uncorrected visual acuity (UCVA) ETDRS testing at distance, intermediate and near in photopic lighting (monocular and binocular) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Best distance-corrected visual acuity (BDCVA) ETDRS testing at distance, intermediate and near in photopic lighting (monocular and binocular) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Uncorrected visual acuity (UCVA) ETDRS testing at distance, intermediate and near in mesopic lighting (monocular and binocular) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Best distance-corrected visual acuity (BDCVA) ETDRS testing at distance, intermediate and near in mesopic lighting (monocular and binocular) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Photopic and mesopic pupillometry [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
TECNIS MULTIFOCAL (TMF) INTRAOCULAR LENS
CRYSTALENS HD (CHD) INTRAOCULAR LENS

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Evaluate visual acuity in different lighting conditions (daylight and night time) and distances (distance, near and intermediate), and the independence of glasses, in patients who have had binocular implantation of the Tecnis Multifocal IOL or the Crystalens™ HD Accommodating IOL.

Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Status post bilateral cataract or refractive lens surgery (with or without LRI) and implantation of Tecnis™ Multifocal IOL or Crystalens™ HD Accommodating IOL
  • Best-corrected ETDRS equivalent visual acuity of 20/30 or better in each eye
  • Naturally dilated pupil size (in dim light) > 3.5 mm (with no dilation medications) for both eyes
  • Clear intraocular media (no posterior capsular opacification, or status post YAG capsulotomy)
  • Availability, willingness, and sufficient cognitive awareness to comply with examination procedures

Exclusion Criteria:

  • Ocular disease which could potentially limit uncorrected visual acuity or visual performance.
  • Use of systemic or ocular medications that may affect visual outcomes
  • Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)
  • Uncontrolled systemic or ocular disease
  • History of ocular trauma
  • History of ocular surgery other than that required for inclusion in this study
  • Amblyopia or strabismus
  • Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)
  • Diagnosed degenerative visual disorders (e.g. macular degeneration, or other retinal disorders) that are predicted to cause future acuity losses to a level of worse than 20/30
  • Subjects who may be expected to require retinal laser treatment or other surgical intervention
  • Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
  • Pupil abnormalities (non-reactive, tonic pupils or abnormally shaped pupils)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01191502

Locations
United States, Oregon
Oregon Health & Sciences University
Eugene,, Oregon, United States, 97401
Sponsors and Collaborators
Innovative Medical
  More Information

No publications provided

Responsible Party: Mark Packer, Oregon Health & Sciences University
ClinicalTrials.gov Identifier: NCT01191502     History of Changes
Other Study ID Numbers: TMF-09-002
Study First Received: August 27, 2010
Last Updated: October 5, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Innovative Medical:
Patients who have had binocular implantation of the Tecnis Multifocal IOL or the Crystalens™ HD Accommodating IOL.

ClinicalTrials.gov processed this record on November 25, 2014