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

Sponsor

Innovative Medical (Industry)

Overall Status

Completed

CT.gov ID

NCT01191229

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Incision size [1 year]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	JacksonEye	Lake Villa	Illinois	United States	60046

Sponsors and Collaborators

Innovative Medical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01191229

Other Study ID Numbers:

Tecnis One-Piece MF IOL

First Posted:

Aug 30, 2010

Last Update Posted:

Jun 14, 2012

Last Verified:

Jun 1, 2012

Study Results

No Results Posted as of Jun 14, 2012