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

August 27, 2010
October 5, 2011
January 2010
September 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01191502 on ClinicalTrials.gov Archive Site
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Comparative Study of Photopic and Mesopic Distance, Intermediate and Near Visual Acuity, and Spectacle Independence
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

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Retrospective
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Non-Probability Sample

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.

Visual Acuity
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  • TECNIS MULTIFOCAL (TMF) INTRAOCULAR LENS
  • CRYSTALENS HD (CHD) INTRAOCULAR LENS
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
September 2011
September 2011   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01191502
TMF-09-002
No
Mark Packer, Oregon Health & Sciences University
Innovative Medical
Not Provided
Not Provided
Innovative Medical
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP