Clinical Investigation of Refraction Techniques

Johnson & Johnson (J&J)

Status: Completed

Conditions: Refractive Error

Treatments: Device: Refractive Technique (MR #1); Device: Refractive Technique (MR #2)

Study type: Observational

Funder types: Industry

Identifiers

NCT05461586

MDEV104MREE

Details and patient eligibility

About

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).

Enrollment: 35 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

35 participants in 2 patient groups

MR #1/MR #2

Description:

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.

Treatment:

Device: Refractive Technique (MR #2)

Device: Refractive Technique (MR #1)

MR#2/MR#1

Description:

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.

Treatment:

Device: Refractive Technique (MR #2)

Device: Refractive Technique (MR #1)