Clinical Investigation of Refraction Techniques

NCT05461586 | Completed

• 1 other identifier: MDEV104MREE
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Refractive Error

Outcome Measures

Primary Outcomes (2)

• Difference between two manifest refractive techniques on outcome variable MRSE

  Refractive technique 1 will use a plus lens fogging technique and refractive technique 2 will use the Duochrome technique to achieve maximum plus refraction for best-corrected visual acuity (BCDVA).

  Day 0

• Difference between two manifest refractive techniques on visual acuity

  Refractive technique 1 will use a plus lens fogging technique and refractive technique 2 will use the Duochrome technique to achieve maximum plus refraction for best-corrected visual acuity (BCDVA).

  Day 0

Study Arms (2)

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.

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

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.

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

Interventions

Refractive Technique (MR #1) DEVICE

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

MR #1/MR #2; MR#2/MR#1

Refractive Technique (MR #2) 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 #1/MR #2; MR#2/MR#1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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;
• At least one implanted eye with clear ocular media;
• 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;
• Availability, willingness and sufficient cognitive awareness to comply with examination procedures.

You may not qualify if:

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

Sponsors & Collaborators

• Johnson & Johnson Surgical Vision, Inc.: lead

Study Sites (1)

Sunshine Eye Clinic

Birtinya, Queensland, 4575, Australia

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Johnson & Johnson Surgical Vision, Inc. Clinical Trial

  Johnson & Johnson Surgical Vision, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 18, 2022
• Study Start: July 14, 2022
• Primary Completion: August 9, 2022
• Study Completion: August 9, 2022
• Last Updated: January 6, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)