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CompletedNCT01191502Updated Oct 6, 2011

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

An observational study in Visual Acuity, sponsored by Innovative Medical. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-10-06.

Sponsored by Innovative Medical · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Visual Acuity

Keywords

  • Patients who have had binocular implantation of the Tecnis Multifocal IOL or the Crystalens™ HD Accommodating IOL.
03

In context

Lead sponsor

Innovative Medical is the lead sponsor of 50 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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)
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
50 participants (estimated)

Groups and cohorts

  • TECNIS MULTIFOCAL (TMF) INTRAOCULAR LENS
  • CRYSTALENS HD (CHD) INTRAOCULAR LENS
06

What researchers measure

Primary outcomes

  1. Manifest refraction (monocular)

    Time frame: 1 year

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

    Time frame: 1 year

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

    Time frame: 1 year

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

    Time frame: 1 year

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

    Time frame: 1 year

  6. Photopic and mesopic pupillometry

    Time frame: 1 year

07

Study locations

1 site
  • Oregon Health & Sciences University
    Eugene,, Oregon 97401, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01191502
Lead sponsor
Innovative Medical
First posted
Aug 30, 2010
Start date
Jan 2010
Primary completion
Sep 2011
Completion
Sep 2011
Last update
Oct 6, 2011

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

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