Three Intraocular Lenses Designed to Improve Distance, Intermediate and Near Vision Following Lens Extraction

NCT01225952 | Completed Phase 4 Results

• 1 other identifier: 656
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to compare the contrast sensitivity, high and low contrast visual acuity (VA), glare meter outcomes, and subject satisfaction with three different FDA-approved intraocular lenses (IOLs) designed to improve distance, intermediate, and near vision following lens extraction in adults at least 40 years of age.

Conditions

Cataract

Keywords

phacoemulsification; intraocular lens

Outcome Measures

Primary Outcomes (8)

• Monocular Mesopic Contrast Sensitivity Without Glare (1.5, 3 Cycles/Degree)

  A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.

  Postoperative visit 3 (day 30-60)

• Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)

  A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.

  Postoperative visit 3 (day 30-60)

• Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)

  A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.

  Postoperative visit 3 (day 30-60)

• Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)

  A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.

  Postoperative visit 3 (day 30-60)

• Monocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)

  A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.

  Postoperative visit 4 (day 120-180)

• Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)

  A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.

  Postoperative visit 4 (day 120-180)

• Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)

  A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.

  Postoperative visit 4 (day 120-180)

• Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)

  A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.

  Postoperative visit 4 (day 120-180)

Secondary Outcomes (18)

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

  Postoperative visit 3 (day 30-60)

• Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)

  Postoperative visit 3 (day 30-60)

• Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)

  Postoperative visit 3 (day 30-60)

• Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)

  Postoperative visit 3 (day 30-60)

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

  Postoperative visit 4 (day 120-180)

Study Arms (3)

Crystalens AO

EXPERIMENTAL

Bausch \& Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens

Device: Crystalens AO

ReSTOR 3.0

ACTIVE COMPARATOR

An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.

Device: ReSTOR 3.0

AMO Tecnis Multifocal

ACTIVE COMPARATOR

A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL

Device: AMO Tecnis Multifocal

Interventions

Crystalens AO DEVICE

Bausch \& Lomb model silicone multi-piece accommodating IOL.

Crystalens AO

ReSTOR 3.0 DEVICE

An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.

ReSTOR 3.0

AMO Tecnis Multifocal DEVICE

The Tecnis Multifocal foldable hydrophobic acrylic IOL, Model ZMA00 (Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL.

AMO Tecnis Multifocal

Eligibility Criteria

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

You may qualify if:

• Subjects must be undergoing primary IOL implantation for the correction of aphakia following continuous curvilinear anterior capsulotomy and phacoemulsification cataract extraction.
• Subjects must require a spherical lens power from 10.00 diopters (D) to 33.00 D.
• Subjects must have the potential for corrected distance visual acuity (CDVA) of 20/32 or better in both eyes.
• Subjects must have stopped contact lens wear for at least two weeks for soft lens wearers or three weeks for gas permeable lens wearers prior to biometry and surgery.
• At the time of surgery, subjects must have an intact centered capsulorhexis, intact posterior capsule, and no zonular rupture.
• Subjects must have ≤ 1.25 D of preoperative corneal astigmatism in both eyes.

You may not qualify if:

• Subjects with diagnoses of degenerative visual disorders (eg, macular degeneration, or other retinal disorders) that cause potential acuity losses to a level of 20/32 or worse.
• Subjects with conditions with increased risk of zonular rupture, such as pseudoexfoliation syndrome.
• 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 uncontrolled glaucoma.
• Subjects with previous retinal detachment.
• Subjects with visually significant diabetic retinopathy (proliferative or nonproliferative) which reduces potential acuity to 20/32 or worse.
• Subjects with rubella, bilateral congenital, traumatic, complicated or polar cataract.
• Subjects with marked microphthalmos or aniridia.
• Subjects who have had previous corneal surgery.
• Subjects with irregular corneal astigmatism.
• Subjects with amblyopia which reduces potential acuity to 20/32 or worse.
• Subjects with optic atrophy.
• Subjects with iris neovascularization.
• Subjects with clinically significant retinal pigment epithelium/macular changes which reduces potential acuity to 20/32 or worse.
• Subjects with chronic use of systemic steroids or immunosuppressive medications.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Asian Eye Institute

Makati City, 1200, Philippines

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Omid Khodai, OD,RAC
• Organization: Bausch & Lomb Incorporated

omid.khodai@bausch.com

(949) 521-7894

Study Officials

• Tes Ignacio, MD

  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: October 19, 2010
• First Posted: October 21, 2010
• Study Start: July 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: January 18, 2013
• Results First Posted: January 18, 2013

Record last verified: 2012-12

Locations

PH (1)