Clinical Investigation of Refraction Techniques

Completed

• Conditions: Refractive Error
• Interventions: Device: Refractive Technique (MR #1); Device: Refractive Technique (MR #2)

• Registration Number: NCT05461586
• Lead Sponsor: Johnson & Johnson Surgical Vision, Inc.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-07
• Study First Submitted QC: 2022-07-13
• Study Start: 2022-07-14
• Study First Posted: 2022-07-18
• Primary Completion: 2022-08-09
• Study Completion: 2022-08-09
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-04
• Last Update Posted: 2023-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MR#2/MR#1	Refractive Technique (MR #2)	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.
MR #1/MR #2	Refractive Technique (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.
MR#2/MR#1	Refractive Technique (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.
MR #1/MR #2	Refractive Technique (MR #1)	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.

Primary Outcome Measures

Name	Time	Method
Difference between two manifest refractive techniques on visual acuity	Day 0	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).
Difference between two manifest refractive techniques on outcome variable MRSE	Day 0	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).

Trial Locations

Locations (1)

Sunshine Eye Clinic; 🇦🇺 Birtinya, Queensland, Australia