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Evaluation of the Tecnis™ Multifocal and Crystalens™ Accommodating Intraocular Lenses

Primary Purpose

Aphakia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tecnis MF IOL
Crystalens AO IOL
Sponsored by
Innovative Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphakia focused on measuring Aphakia following refractive lensectomy to treat presbyopia

Eligibility Criteria

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

Inclusion Criteria:

  • Age 18 or greater
  • Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation has been planned for both eyes
  • Visual potential of 20/25 or better in each eye after cataract removal and IOL implantation
  • Preoperative best-corrected distance visual acuity (BCDVA) worse than 20/40 Snellen
  • Naturally dilated pupil size (in dim light) > 4.0 mm (with no dilation medications) for both eyes
  • Preoperative corneal astigmatism of 1.0 D or less
  • Clear intraocular media other than cataract
  • Availability, willingness, and sufficient cognitive awareness to comply with examination procedures

Exclusion Criteria:

  • Use of systemic or ocular medications that may affect vision
  • Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)
  • Subjects with diabetes mellitus
  • Uncontrolled systemic or ocular disease
  • History of ocular trauma or prior ocular surgery
  • 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 20/30 or worse
  • 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, abnormally shaped pupils, or pupils that do not dilate at least 4.0 mm under mesopic/scotopic conditions)
  • Contact lens usage within 6 months for PMMA contacts lenses, 1 month for gas permeable lenses or 1 week for extended-wear and daily-wear soft contact lenses
  • Requiring an intraocular lens < 15.0 or > 26.0 diopters

Sites / Locations

  • Farrell Tyson

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Tecnis MF IOL

Crystalens AO IOL

Arm Description

Outcomes

Primary Outcome Measures

Refraction
Distance Visual Acuities

Secondary Outcome Measures

Full Information

First Posted
February 1, 2010
Last Updated
January 13, 2012
Sponsor
Innovative Medical
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1. Study Identification

Unique Protocol Identification Number
NCT01061281
Brief Title
Evaluation of the Tecnis™ Multifocal and Crystalens™ Accommodating Intraocular Lenses
Official Title
Evaluation of the Tecnis™ Multifocal and Crystalens™ Accommodating Intraocular Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Innovative Medical

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the visual outcomes with bilateral implantation of Tecnis MF and Crystalens™ AO Aberration-free Accommodating intraocular lens (IOLs) 6 months after post cataract surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphakia
Keywords
Aphakia following refractive lensectomy to treat presbyopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tecnis MF IOL
Arm Type
Active Comparator
Arm Title
Crystalens AO IOL
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Tecnis MF IOL
Intervention Description
20 patients enrolled with the Tecnis MF IOL.
Intervention Type
Device
Intervention Name(s)
Crystalens AO IOL
Intervention Description
20 patients enrolled with the Crystalens AO
Primary Outcome Measure Information:
Title
Refraction
Time Frame
1 year
Title
Distance Visual Acuities
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 or greater Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation has been planned for both eyes Visual potential of 20/25 or better in each eye after cataract removal and IOL implantation Preoperative best-corrected distance visual acuity (BCDVA) worse than 20/40 Snellen Naturally dilated pupil size (in dim light) > 4.0 mm (with no dilation medications) for both eyes Preoperative corneal astigmatism of 1.0 D or less Clear intraocular media other than cataract Availability, willingness, and sufficient cognitive awareness to comply with examination procedures Exclusion Criteria: Use of systemic or ocular medications that may affect vision Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.) Subjects with diabetes mellitus Uncontrolled systemic or ocular disease History of ocular trauma or prior ocular surgery 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 20/30 or worse 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, abnormally shaped pupils, or pupils that do not dilate at least 4.0 mm under mesopic/scotopic conditions) Contact lens usage within 6 months for PMMA contacts lenses, 1 month for gas permeable lenses or 1 week for extended-wear and daily-wear soft contact lenses Requiring an intraocular lens < 15.0 or > 26.0 diopters
Facility Information:
Facility Name
Farrell Tyson
City
Cape Coral
State/Province
Florida
Country
United States

12. IPD Sharing Statement

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Evaluation of the Tecnis™ Multifocal and Crystalens™ Accommodating Intraocular Lenses

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