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

NCT01191502 | Completed

• 1 other identifier: TMF-09-002
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Visual Acuity

Keywords

Patients who have had binocular implantation of the Tecnis Multifocal IOL or the Crystalens™ HD Accommodating IOL.

Outcome Measures

Primary Outcomes (6)

• Manifest refraction (monocular)

  1 year

• Uncorrected visual acuity (UCVA) ETDRS testing at distance, intermediate and near in photopic lighting (monocular and binocular)

  1 year

• Best distance-corrected visual acuity (BDCVA) ETDRS testing at distance, intermediate and near in photopic lighting (monocular and binocular)

  1 year

• Uncorrected visual acuity (UCVA) ETDRS testing at distance, intermediate and near in mesopic lighting (monocular and binocular)

  1 year

• Best distance-corrected visual acuity (BDCVA) ETDRS testing at distance, intermediate and near in mesopic lighting (monocular and binocular)

  1 year

• Photopic and mesopic pupillometry

  1 year

Study Arms (2)

TECNIS MULTIFOCAL (TMF) INTRAOCULAR LENS

CRYSTALENS HD (CHD) INTRAOCULAR LENS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Innovative Medical: lead

Study Sites (1)

Oregon Health & Sciences University

Eugene, Oregon, 97401, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 27, 2010
• First Posted: August 30, 2010
• Study Start: January 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 6, 2011

Record last verified: 2011-10

Locations

US (1)