Wavefront Analyzes and Visual Performance of Three Multifocal Intra-ocular Lenses

Phase 1 Study of Ocular Aberrations and Visual Performance of Eyes Implanted With Three Multifocal Intra-ocular Lenses

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00876707

Acronym

IOL

Enrollment

Registered

2009-04-07

Start date

2009-03-31

Completion date

2009-11-30

Last updated

2010-07-02

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

Conditions

Astigmatism, Cataract

Keywords

wavefront, multifocal IOL, modulation transfer function, intraocular lenses, wavefront data, Visual performance

Brief summary

The purpose of this study is to determine if differences in the design of multifocal intra-ocular lenses would mean different values of higher-order aberrations and different performance in objective parameters such as modulation transfer function.

Interventions

DEVICETecnis implant

Implant of diffractive multifocal IOL Tecnis

DEVICEReSTOR implant

Implant of multifocal IOL ReSTOR

DEVICEReZoom implant

Implant of multifocal IOL ReZoom

Study design

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Patients with bilateral visually significant cataract with corneal astigmatism lower than 1.0D

Exclusion criteria

* Any ocular diseases, such as: * corneal opacities or irregularity * dry eye * amblyopia * anisometropia * glaucoma * retinal abnormality * Surgical complications * IOL tilt * IOL decentration greater than 0.4 mm (estimated by retroillumination) * Incomplete follow-up

Design outcomes

Primary

Measure	Time frame
visual acuity, wavefront data and modulation transfer function	30, 90 and 120 days after surgery

Secondary

Measure	Time frame
contrast sensitivity	90 days after surgery

Countries

Brazil

Outcome results

None listed

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