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

Visual Acuity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01191502
• Other study ID #: TMF-09-002
• Status: Completed
• Phase: N/A
• First received: August 27, 2010
• Last updated: October 5, 2011
• Start date: January 2010
• Est. completion date: September 2011

Study information

• Verified date: October 2011
• Source: Innovative Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Visual Acuity

Locations

Country	Name	City	State
United States	Oregon Health & Sciences University	Eugene,	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Innovative Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Manifest refraction (monocular)		1 year	No
Primary	Uncorrected visual acuity (UCVA) ETDRS testing at distance, intermediate and near in photopic lighting (monocular and binocular)		1 year	No
Primary	Best distance-corrected visual acuity (BDCVA) ETDRS testing at distance, intermediate and near in photopic lighting (monocular and binocular)		1 year	No
Primary	Uncorrected visual acuity (UCVA) ETDRS testing at distance, intermediate and near in mesopic lighting (monocular and binocular)		1 year	No
Primary	Best distance-corrected visual acuity (BDCVA) ETDRS testing at distance, intermediate and near in mesopic lighting (monocular and binocular)		1 year	No
Primary	Photopic and mesopic pupillometry		1 year	No