Clinical trial NCT01191502: Comparative Study of Photopic and Mesopic Distance, Intermediate and Near Visual Acuity, and Spectacle Independence
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Visual Acuity
Keywords: Patients who have had binocular implantation of the Tecnis Multifocal IOL or the Crystalens™ HD Accommodating IOL.
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2010-08-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.


Eligibility 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)

Primary outcomes:
measure: Manifest refraction (monocular)
timeFrame: 1 year
measure: Uncorrected visual acuity (UCVA) ETDRS testing at distance, intermediate and near in photopic lighting (monocular and binocular)
timeFrame: 1 year
measure: Best distance-corrected visual acuity (BDCVA) ETDRS testing at distance, intermediate and near in photopic lighting (monocular and binocular)
timeFrame: 1 year
measure: Uncorrected visual acuity (UCVA) ETDRS testing at distance, intermediate and near in mesopic lighting (monocular and binocular)
timeFrame: 1 year
measure: Best distance-corrected visual acuity (BDCVA) ETDRS testing at distance, intermediate and near in mesopic lighting (monocular and binocular)
timeFrame: 1 year
measure: Photopic and mesopic pupillometry
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Eugene,
country: United States
facility: Oregon Health & Sciences University
state: Oregon
Study officials:
References: