Clinical Investigation of Refraction Techniques

Refractive Error Clinical Trial

Official title:

Clinical Investigation of Refraction Techniques

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05461586
• Other study ID #: MDEV104MREE
• Status: Completed
• Start date: July 14, 2022
• Est. completion date: August 9, 2022

Study information

• Verified date: January 2023
• Source: Johnson & Johnson Surgical Vision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: August 9, 2022
• Est. primary completion date: August 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Refractive Error
• Refractive Errors

Intervention

Device:
• Refractive Technique (MR #1)
Fogging method that employs fogging lens to ensure there is sufficient visual defocus to induce blur.
• 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

Locations

Country	Name	City	State
Australia	Sunshine Eye Clinic	Birtinya	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Surgical Vision, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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