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Clinical Investigation of Refraction Techniques

CompletedN/A

Sponsor: Johnson & Johnson Surgical Vision, Inc.

Conditions: Refractive Error

Interventions: Refractive Technique (MR #1), Refractive Technique (MR #2)

Countries: Australia

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).

Eligibility overview

Sex: ALL

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (1)

Birtinya, Queensland, Australia