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OpenTrials
Completed

NCT Number: NCT05461586

Clinical Investigation of Refraction Techniques

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).

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Key information

Conditions

Refractive Error Eye Diseases Refractive Errors

Sex eligibility

All sexes

Study type

Observational

Primary location

Sunshine Eye Clinic

Birtinya, Queensland, 4575, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Refractive Technique (MR #1)

Device

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

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

Primary outcomes

  1. Difference between two manifest refractive techniques on outcome variable MRSE

    Time frame: 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).

  2. Difference between two manifest refractive techniques on visual acuity

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Surgical Vision, Inc.

Industry

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 18, 2022
Registry last updated
Jan 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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