Evaluation of 3 Intraocular Lenses Following Lens Extraction

NCT01122576 | Completed Phase 4 Results

• 1 other identifier: 651
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cataract

Keywords

Intra Ocular Lens; Ocular surgery; Phacoemulsification

Outcome Measures

Primary Outcomes (9)

• Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree

  Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  Postoperative visit 3 (2-3 months)

• Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree

  Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  Postoperative visit 3 (2-3 months)

• Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree

  Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  Postoperative visit 3 (2-3 months)

• Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree

  Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  Postoperative visit 3 (2-3 months)

• Mesopic Monocular Contrast Sensitivity Without Glare 1.5 Cycles/Degree

  Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  Postoperative visit 4 ( 4-6 months)

• Mesopic Monocular Contrast Sensitivity Without Glare 3 Cycles/Degree

  Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  Postoperative visit 4 ( 4-6 months)

• Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree

  Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  Postoperative visit 4 ( 4-6 months)

• Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree

  Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  Postoperative visit 4 ( 4-6 months)

• Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree

  Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  Postoperative visit 4 ( 4-6 months)

Secondary Outcomes (35)

• Binocular Mesopic Contrast Sensitivity Without Glare 1.5 & 3 Cycles/Degree

  Visit 3 (2-3 months)

• Binocular Mesopic Contrast Sensitivity Without Glare 6 Cycles/Degree

  Visit 3 (2-3 months)

• Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree

  Visit 3 (2-3 months)

• Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree

  Visit 3 (2-3 months)

• Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree

  Visit 4 (4-6 months)

Study Arms (3)

Crystalens AO

EXPERIMENTAL

Eligible subjects to undergo small incision cataract surgery and were implanted with the Crystalens AO bilaterally.

Device: Crystalens AO

ReSTOR

ACTIVE COMPARATOR

Eligible subjects to undergo small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.

Device: ReSTOR

Tecnis Multifocal IOL

ACTIVE COMPARATOR

Eligible subjects to undergo small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.

Device: Tecnis Multifocal IOL

Interventions

Crystalens AO DEVICE

Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.

Crystalens AO

ReSTOR DEVICE

ReSTOR surgically implanted bilaterally. Study observation up to 180 days.

ReSTOR

Tecnis Multifocal IOL DEVICE

Tecnis surgically implanted bilaterally. Study observation up to 180 days.

Tecnis Multifocal IOL

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Bausch & Lomb, Inc

Aliso Viejo, California, 92656, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Quintus Ngumah, OD, PhD
• Organization: Bausch & Lomb Incorporated

Quintus.Ngumah@bausch.com

(973) 360-6450

Study Officials

• Omid Khodai, OD, RAC

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2010
• First Posted: May 13, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: September 1, 2012
• Last Updated: March 28, 2014
• Results First Posted: March 28, 2014

Record last verified: 2014-02

Locations

US (1)