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Evaluation of 3 Intraocular Lenses Following Lens Extraction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01122576
First received: May 11, 2010
Last updated: December 21, 2012
Last verified: December 2012
History of Changes
  Purpose

The objective of this study is to evaluate the efficacy and subject satisfaction with three different FDA approved lenses for adults over 40 years of age who desire a reduction in spectacle dependence.


Condition Intervention Phase
Cataract
 Device: Crystalens AO
Device: ReSTOR AOL
Device: Tecnis Multifocal IOL
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Three Arm Prospective Clinical Evaluation of Three FDA Approved Intraocular Lenses Designed to Improve Distance, Intermediate and Near Vision Following Lens Extraction.

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Mesopic contrast sensitivity without glare [ Time Frame: Postoperative visit 3 (2-3 months) & visit 4 (4-6 months) ] [ Designated as safety issue: No ]
    Logarithm of the mesopic contrast sensitivity without glare at five spatial frequencies.


Secondary Outcome Measures:
  • Mesopic contrast sensitivity with glare [ Time Frame: Postoperative visit 3 (2-3 months) & visit 4 (4-6 months) ] [ Designated as safety issue: No ]
    logarithm of the mesopic contrast sensitivity with glare at five spatial frequencies.


Enrollment: 78
Study Start Date: June 2010
Study Completion Date: September 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Crystalens AO
Eligible subjects will undergo small incision cataract surgery and implanted with the Crystalens AO bilaterally.
 Device: Crystalens AO
Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
Active Comparator: ReSTOR
Eligible subjects will undergo small incision cataract surgery and implanted with the ReSTOR IOL bilaterally.
 Device: ReSTOR AOL
ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
Active Comparator: Tecnis Multifocal IOL
Eligible subjects will undergo small incision cataract surgery and implanted with the Tecnis Multifocal IOL bilaterally.
 Device: Tecnis Multifocal IOL
ReSTOR surgically implanted bilaterally. Study observation up to 180 days.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must have a clinically documented diagnosis of age-related bilateral cataracts that are considered amenable to treatment with standard phacoemulsification cataract extraction.
  • Subjects must require a spherical lens power from 10.00 D to 33.00 D
  • Subjects must have the potential for corrected distance visual acuity (CDVA) of 20/32 or better in both eyes, as documented by a Potential Acuity Meter

Exclusion Criteria:

  • Subjects with conditions with increased risk of zonular rupture, such as pseudoexfoliation syndrome. Zonular rupture during cataract surgery may affect postoperative centration, tilt, and stability of the lens.
  • Subjects who have any active inflammation or edema (swelling) of the cornea, including but not limited to the following: keratitis, keratoconjunctivitis, and keratouveitis.
  • Subjects with visually significant diabetic retinopathy (proliferative or non-proliferative) which reduces potential acuity to 20/32 or worse.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01122576

Locations
United States, California
Bausch & Lomb, Inc
Aliso Viejo, California, United States, 92656
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Omid Khodai, OD, RAC Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01122576     History of Changes
Other Study ID Numbers: 651
Study First Received: May 11, 2010
Last Updated: December 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Bausch & Lomb Incorporated:
Intra Ocular Lens
Ocular surgery
Phacoemulsification

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013