Clinical Investigation of Refraction Techniques

NCT ID: NCT05461586

Last Updated: 2023-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-14

Study Completion Date

2022-08-09

Brief Summary

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Prospective, multi-center, non-interventional, randomized, comparative clinical study to identify an optimal refractive technique that provides maximum plus refractive endpoint for best corrected distance visual acuity (BCDVA).

Detailed Description

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Conditions

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Refractive Error

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MR #1/MR #2

Subjects who participated in PCOL-102-AHSF who were bilaterally implanted with TECNIS IOL lenses will be randomized into the (MR #1/MR #2) sequence and receive two different maximum refractive techniques one at a time consecutively.

Refractive Technique (MR #1)

Intervention Type DEVICE

Fogging method that employs fogging lens to ensure there is sufficient visual defocus to induce blur.

Refractive Technique (MR #2)

Intervention Type DEVICE

Duochrome method that employs the chromatic aberration of the eye, with the shorter wavelengths (green) focused in front of the longer (red) wavelengths

MR#2/MR#1

Subjects who participated in PCOL-102-AHSF who were bilaterally implanted with TECNIS IOL lenses will be randomized into the (MR#2/MR#1) sequence and receive two different maximum refractive techniques one at a time consecutively.

Refractive Technique (MR #1)

Intervention Type DEVICE

Fogging method that employs fogging lens to ensure there is sufficient visual defocus to induce blur.

Refractive Technique (MR #2)

Intervention Type DEVICE

Duochrome method that employs the chromatic aberration of the eye, with the shorter wavelengths (green) focused in front of the longer (red) wavelengths

Interventions

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Refractive Technique (MR #1)

Fogging method that employs fogging lens to ensure there is sufficient visual defocus to induce blur.

Intervention Type DEVICE

Refractive Technique (MR #2)

Duochrome method that employs the chromatic aberration of the eye, with the shorter wavelengths (green) focused in front of the longer (red) wavelengths

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Participant in PCOL-102-AHSF who were bilaterally implanted with TECNIS IOL, Models C1V000, C2V000 or ICB00 and have completed and are at least 30 days postoperative from their second eye surgery;
2. At least one implanted eye with clear ocular media;
3. Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in Australia and New Zealand;
4. Availability, willingness and sufficient cognitive awareness to comply with examination procedures.

Exclusion Criteria

1. Best-corrected distance visual acuity (BCDVA) worse than 0.66 decimal (6/9 or 20/30 Snellen);
2. Subjects with ongoing adverse events that might impact outcomes during the study visit as determined by the investigator.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson & Johnson Surgical Vision, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johnson & Johnson Surgical Vision, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Surgical Vision, Inc.

Locations

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Sunshine Eye Clinic

Birtinya, Queensland, Australia

Site Status

Countries

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Australia

Other Identifiers

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MDEV104MREE

Identifier Type: -

Identifier Source: org_study_id

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