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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01191229

Enrollment

Registered

2010-08-30

Start date

2010-07-31

Completion date

2012-06-30

Last updated

2012-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

To Collect Information About Visual Outcomes and Participant Satisfaction

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.

Interventions

DEVICETecnis one-piece MF IOL

25 patients to be implanted after cataract surgery

DEVICECrystalens AO

25 patients that are previously implanted

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026