Clinical Investigation of Refraction Techniques
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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)
Fogging method that employs fogging lens to ensure there is sufficient visual defocus to induce blur.
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
|
| 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)
Fogging method that employs fogging lens to ensure there is sufficient visual defocus to induce blur.
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
|
Outcome Measures
Primary Outcome Measures
- 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).
- 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).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sunshine Eye Clinic | Birtinya | Queensland | Australia | 4575 |
Sponsors and Collaborators
- Johnson & Johnson Surgical Vision, Inc.
Investigators
- Study Director: Johnson & Johnson Surgical Vision, Inc. Clinical Trial, Johnson & Johnson Surgical Vision, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MDEV104MREE