Clinical Investigation of the Next Generation Intraocular Lens

Not Applicable

Completed

• Conditions: Cataract

• Registration Number: NCT03500198
• Lead Sponsor: Johnson & Johnson Surgical Vision, Inc.

Brief Summary

An investigational IOL designed to provide improved intermediate and near visual acuity and decreased spectacle wear was evaluated for safety and effectiveness in a six-month study.

Detailed Description

The next generation TECNIS IOL designed to provide improved intermediate and near visual acuity and decreased spectacle wear was evaluated for safety and effectiveness in a six-month interventional study and compared to a marketed monofocal IOL. Assessments included distance-corrected intermediate and near visual acuity, depth of focus at 0.2 logMAR and spectacle wear frequency.

Study Timeline

• Study First Submitted: 2018-04-09
• Study First Submitted QC: 2018-04-09
• Study First Posted: 2018-04-18
• Study Start: 2018-06-28
• Primary Completion: 2019-06-05
• Study Completion: 2019-06-05
• Results First Submitted: 2020-05-29
• Status Verified: 2020-06
• Results First Submitted QC: 2020-06-24
• Last Update Submitted: 2020-06-24
• Results First Posted: 2020-06-25
• Last Update Posted: 2020-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 247

Inclusion Criteria

• Minimum 22 years of age
• Bilateral cataracts for which posterior chamber IOL implantation has been planned
• Corneal astigmatism:
• Normal corneal topography
• Availability, willingness and sufficient cognitive awareness to comply with examination procedures and study visits
• Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries
• Ability to understand and respond to a questionnaire in English

Exclusion Criteria

• Irregular corneal astigmatism
• Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
• Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery, Including prophylactic peripheral iridotomies and peripheral laser retinal repairs
• Poorly-controlled diabetes
• Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes
• Concurrent participation or participation within 60 days prior to preoperative visit in any other clinical trial
• Desire for monovision correction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Monocular, Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeter (cm)	6 months (postoperative)	Visual Acuity (VA) was assessed monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction (distance refraction) and high contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 66 cm from spectacle plane. It was measured in logarithm of the minimum angle of resolution (logMAR), on an ETDRS chart. A lower numeric value represented better VA. This analysis was pre-specified for the first operative eye only.
Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve	6 months (postoperative)	Depth of focus was assessed using best corrected distance refraction, and 100% contrast ETDRS letters. VA was measured between +2.00 Diopter (D) and -4.00 D in 0.5 D defocus steps. VA was measured in logMAR. The depth of focus was estimated as the dioptric range between zero defocus and the first point on the negative lens induced mean defocus curve that crosses the 0.2 logMAR using a linear interpolation. A lower numeric value represents better VA. This analysis was pre-specified to be reported for the first operative eye only.

Secondary Outcome Measures

Name	Time	Method
Monocular, Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm	6 months (postoperative)	Visual acuity was tested monocularly under photopic conditions using best distance correction (distance refraction) and high contrast, ETDRS chart set at 40 cm from the spectacle plane using the near point rod. VA was measured in logMAR on an ETDRS chart. A lower numeric value represented better VA. This analysis was pre-specified to be reported for the first operative eye only.
Overall Spectacle Wear	6 months (postoperative)	Overall spectacle wear was determined for participants wearing glasses or contact lenses using Patient-Reported Spectacle Independence Questionnaire (PRSIQv2) asking if their response is 'none of the time' in all the 4 conditions (distance vision, intermediate vision, near vision and overall vision) of the spectacle wear questions were reported. PRSIQv2 questionnaire responses were divided into two response groups: reports of "none of the time" and the combined reports of "a little of the time," "some of the time," "most of the time," or "all of the time".

Trial Locations

Locations (10)

The Eye Associates of Manatee, LLP; 🇺🇸 Bradenton, Florida, United States

Cincinnati Eye Institute; 🇺🇸 Cincinnati, Ohio, United States

Berkeley Eye Institute, P.A.; 🇺🇸 Houston, Texas, United States

Eye Care Specialists; 🇺🇸 Kingston, Pennsylvania, United States

Key-Whitman Eye Center; 🇺🇸 Dallas, Texas, United States

Wolstan & Goldberg Eye Associates; 🇺🇸 Torrance, California, United States

Levenson Eye Associates, Inc.; 🇺🇸 Jacksonville, Florida, United States

Jones Eye Clinic; 🇺🇸 Sioux City, Iowa, United States

Slade & Baker Vision; 🇺🇸 Houston, Texas, United States

Vance Thompson Vision Clinic, Prof LLC; 🇺🇸 Sioux Falls, South Dakota, United States