Prospective Evaluation of Visual Outcomes With Tecnis One-Piece Multifocal Intraocular Lenses Compared With Patients Previously Implanted With Crystalens Aspheric Optic (AO)

This study has been completed.
Sponsor:
Information provided by:
Innovative Medical
ClinicalTrials.gov Identifier:
NCT01191229
First received: August 19, 2010
Last updated: June 13, 2012
Last verified: June 2012
  Purpose

The study is being conducted to collect information about visual outcomes and participant satisfaction with the Tecnis One-Piece Multifocal (MF) Intraocular Lenses (IOLs) compared with participants previously implanted with Crystalens Aspheric Optic (AO) IOLs. The U.S. Food and Drug Administration (FDA) has cleared the Tecnis One-Piece MF IOL for visual correction of aphakia (replacing a removed lens in the eye) in adults.


Condition Intervention Phase
To Collect Information About Visual Outcomes and Participant Satisfaction
Device: Tecnis one-piece MF IOL
Device: Crystalens AO
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Visual Outcomes With Tecnis One-Piece Multifocal Intraocular Lenses Compared With Patients Previously Implanted With Crystalens AO

Further study details as provided by Innovative Medical:

Primary Outcome Measures:
  • Incision size [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    Part 1 Only:

    The primary outcome measure is incision size at three points:

    Immediately after application of the keratome blade Post phacoemulsification Post Tecnis IOL implantation Target refraction vs. achieved

    Part 1 and 2:

    UCVA data at distance, intermediate, and near Near vision will be measured in mesopic and photopic conditions standardized with light meter BCVA at distance and near Enhancement rates Spectacle independence questionnaire and patient satisfaction Incidence of adverse events



Enrollment: 12
Study Start Date: July 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Tecnis One-Piece MF IOL
It is planned that about 25 people who are at least 18 years old who are scheduled to have the Tecnis One-Piece Multifocal Intraocular Lenses placed into their eyes after cataract surgery
Device: Tecnis one-piece MF IOL
25 patients to be implanted after cataract surgery
No Intervention: Crystalens AO
It is planned that about 25 people who are at least 18 years old and have been implanted with Crystalens AO
Device: Crystalens AO
25 patients that are previously implanted

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Key Inclusion Criteria for Part 1:

    • Age 18 or greater
    • Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation has been planned for both eyes
    • Visual potential of 20/30 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) > 3.5 mm (with no dilation medications) for both eyes
    • Preoperative corneal astigmatism of 1.5 D or less
    • Clear intraocular media other than cataract
    • Availability, willingness, and sufficient cognitive awareness to comply with examination procedures

Inclusion Criteria for Part 2

  • At least 18 years of age
  • Underwent bilateral implantation with Crystalens AO at least 6 months previously
  • Visual potential of 20/30 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) > 3.5 mm (with no dilation medications) for both eyes
  • Preoperative corneal astigmatism of 1.5 D or less
  • Clear intraocular media other than cataract
  • Availability, willingness, and sufficient cognitive awareness to comply with examination procedures

Exclusion Criteria:

  • Key Exclusion Criteria for Part 1:

    • 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
    • Patients with forme fruste keratoconus or keratoconus
    • 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

Exclusion Criteria for Part 2

  • 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
  • Patients with forme fruste keratoconus or keratoconus
  • 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)
  • Requiring an intraocular lens <15.0 or >26.0 diopters Exclusion Criteria for Part 2
  • 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
  • Patients with forme fruste keratoconus or keratoconus
  • 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)
  • Requiring an intraocular lens <15.0 or >26.0 diopters
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01191229

Locations
United States, Illinois
JacksonEye
Lake Villa, Illinois, United States, 60046
Sponsors and Collaborators
Innovative Medical
  More Information

No publications provided

Responsible Party: Mitch Jackson, MD, JacksonEye
ClinicalTrials.gov Identifier: NCT01191229     History of Changes
Other Study ID Numbers: Tecnis One-Piece MF IOL
Study First Received: August 19, 2010
Last Updated: June 13, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 20, 2014