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Accommodation Measurements After Bilateral Implantation of an Aspheric Accommodating Lens and Monofocal Aspheric Lenses

Primary Purpose

Cataract

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Crystalens AO
SoftPort LI61AO
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring cataract surgery, intraocular lens

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects must have clear intraocular media other than cataract.
  • 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 be undergoing primary IOL implantation for the correction of aphakia following central continuous curvilinear anterior capsulorrhexis and phacoemulsification cataract extraction.
  • Subjects must require a spherical lens power from 10.00 D to 30.00 D.
  • Subjects must be willing and able to return for all scheduled follow-up examinations for each eye from days 1 through 180 following surgery.
  • Subjects must have ≤ 1.25 D of preoperative corneal astigmatism.

Exclusion Criteria:

  • Subjects with corneal pathology potentially affecting topography.
  • Subjects whose fundus cannot be assessed preoperatively.
  • Subjects with diagnoses of degenerative visual disorders (eg, macular degeneration, or other retinal disorders) that cause potential acuity losses to a level worse than 20/30 as verified by OCT.
  • 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 non-proliferative) which reduces potential acuity to 20/30 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 worse than 20/30.
  • Subjects with optic atrophy.
  • Subjects with iris neovascularization.
  • Subjects with clinically significant retinal pigment epithelium/macular changes which reduces potential acuity to 20/30 or worse.
  • Subjects with chronic use of systemic steroids or immunosuppressive medications.
  • Subjects lacking intact binocular vision.

Sites / Locations

  • Bausch & Lomb

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Crystalens AO

SoftPort LI61AO

Arm Description

A silicone multi-piece accommodating intraocular lens

A silicone multi-piece foldable aspheric intraocular lens

Outcomes

Primary Outcome Measures

Amplitude of Accommodation
The measurement of optical change in the power of the eye when viewing from far to near. Accommodation decreases as age increases resulting in an inability to focus on near objects.

Secondary Outcome Measures

Visual Acuity
Number of correct letters on an early treatment diabetic retinopathy study (ETDRS) chart to measure distance visual acuity and the smallest readable print size on an Minnesota Low-Vision Reading (MNREAD) acuity chart for intermediate and near visual acuity (VA). Visual acuity measured in LogMAR.

Full Information

First Posted
November 12, 2010
Last Updated
November 25, 2014
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01241279
Brief Title
Accommodation Measurements After Bilateral Implantation of an Aspheric Accommodating Lens and Monofocal Aspheric Lenses
Official Title
A Two Arm Prospective, Randomized, Double-Masked Clinical Evaluation of Accommodation Measurements After Bilateral Implantation of an Aspheric Accommodating Lens and Monofocal Aspheric Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to low enrollment
Study Start Date
October 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to demonstrate the correlation of near vision and changes in higher order aberrations following lens extraction and to characterize the defocus curves of Crystalens® AO™ intraocular lens (IOL) versus the monofocal aspheric SofPort® LI61AO IOL in adults.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
cataract surgery, intraocular lens

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Crystalens AO
Arm Type
Experimental
Arm Description
A silicone multi-piece accommodating intraocular lens
Arm Title
SoftPort LI61AO
Arm Type
Active Comparator
Arm Description
A silicone multi-piece foldable aspheric intraocular lens
Intervention Type
Device
Intervention Name(s)
Crystalens AO
Intervention Description
Participants will undergo small incision cataract surgery (phacoemulsification). At the time of surgery, eligible participants will be implanted bilaterally with the Crystalens AO intraocular lens.
Intervention Type
Device
Intervention Name(s)
SoftPort LI61AO
Intervention Description
Participants will undergo small incision cataract surgery (phacoemulsification). At the time of surgery, eligible participants will be implanted bilaterally with the SoftPort LI61AO intraocular lens.
Primary Outcome Measure Information:
Title
Amplitude of Accommodation
Description
The measurement of optical change in the power of the eye when viewing from far to near. Accommodation decreases as age increases resulting in an inability to focus on near objects.
Time Frame
Visit 4 (postoperative day 120-180)
Secondary Outcome Measure Information:
Title
Visual Acuity
Description
Number of correct letters on an early treatment diabetic retinopathy study (ETDRS) chart to measure distance visual acuity and the smallest readable print size on an Minnesota Low-Vision Reading (MNREAD) acuity chart for intermediate and near visual acuity (VA). Visual acuity measured in LogMAR.
Time Frame
All visits through visit 4 (day 160-180)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must have clear intraocular media other than cataract. 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 be undergoing primary IOL implantation for the correction of aphakia following central continuous curvilinear anterior capsulorrhexis and phacoemulsification cataract extraction. Subjects must require a spherical lens power from 10.00 D to 30.00 D. Subjects must be willing and able to return for all scheduled follow-up examinations for each eye from days 1 through 180 following surgery. Subjects must have ≤ 1.25 D of preoperative corneal astigmatism. Exclusion Criteria: Subjects with corneal pathology potentially affecting topography. Subjects whose fundus cannot be assessed preoperatively. Subjects with diagnoses of degenerative visual disorders (eg, macular degeneration, or other retinal disorders) that cause potential acuity losses to a level worse than 20/30 as verified by OCT. 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 non-proliferative) which reduces potential acuity to 20/30 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 worse than 20/30. Subjects with optic atrophy. Subjects with iris neovascularization. Subjects with clinically significant retinal pigment epithelium/macular changes which reduces potential acuity to 20/30 or worse. Subjects with chronic use of systemic steroids or immunosuppressive medications. Subjects lacking intact binocular vision.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson Varughese
Organizational Affiliation
Valeant Pharmaceuticals/Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Bausch & Lomb
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States

12. IPD Sharing Statement

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Accommodation Measurements After Bilateral Implantation of an Aspheric Accommodating Lens and Monofocal Aspheric Lenses

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