Clinical Investigation of Two Tecnis Investigational Lenses

Sponsor
Johnson & Johnson Surgical Vision, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04890249
Collaborator
(none)
225
Enrollment
5
Locations
3
Arms
11.2
Anticipated Duration (Months)
45
Patients Per Site
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a 6-month, prospective, multicenter, randomized (1:1:1), subject-masked and evaluator-masked, bilateral clinical investigation of the TECNIS IOL Models C1V000 and C2V000 versus the TECNIS Eyhance™ Model ICB00 IOL.

The study will be conducted at up to 15 sites in EU, AU, NZ and/or AP and will enroll up to 225 subjects to achieve approximately 67 bilaterally implanted subjects in each lens group. Allowing for 10% lost-to-follow-up, this will achieve approximately 60 evaluable subjects in each lens group at 1, 3, and 6 months. The eye implanted first will be considered the primary (monocular) study eye.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Investigational IOL Model C1V000
  • Device: Investigational IOL Model C2V000
  • Device: Control IOL Model ICB00
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
225 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Other
Official Title:
Clinical Investigation of the TECNIS® Intraocular Lens, Models C1V000 and C2V000
Actual Study Start Date :
Jun 23, 2021
Anticipated Primary Completion Date :
May 31, 2022
Anticipated Study Completion Date :
May 31, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Investigational Lens Device #1

Investigational IOL Model C1V000

Device: Investigational IOL Model C1V000
IOL replaces the natural lens removed during cataract surgery.

Experimental: Investigational Lens Device #2

Investigational IOL Model C2V000

Device: Investigational IOL Model C2V000
IOL replaces the natural lens removed during cataract surgery.

Active Comparator: Control Lens

Control IOL Model ICB00

Device: Control IOL Model ICB00
IOL replaces the natural lens removed during cataract surgery.

Outcome Measures

Primary Outcome Measures

  1. Monocular Photopic distance-corrected intermediate visual acuity [6 months]

  2. Monocular Photopic best-corrected distance visual acuity [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Minimum 22 years of age

  • Bilateral cataracts or planned natural lens removal (due to immature cataract) for which phacoemulsification extraction and posterior IOL implantation have been planned for both eyes

  • Cataractous lens changes, as demonstrated by best-corrected distance visual acuity (BCDVA) of 0.50 decimal or worse (6/12 or 20/40 Snellen) either with or without a glare source present (e.g., Brightness Acuity Tester) or with significant cataract-related visual symptoms in the opinion of the investigator

  • Potential postoperative best-corrected distance visual acuity (BCDVA) of 0.66 decimal (6/9 or 20/30 Snellen) or better

  • Corneal astigmatism:

  • Normal corneal topography

  • Predicted postoperative corneal astigmatism of less than 1.00 D in both eyes, including posterior corneal astigmatism (PCA)

  • Clear intraocular media other than cataract

  • Signed informed consent for participation in the study and data protection

  • Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures and study visits

  • Ability to understand, read, and write English or the local language in which the informed consent and questionnaires are provided.

Exclusion Criteria:
  • Requiring an intraocular lens power outside the available range of +14.0 D to +26.0 D

  • Any clinically significant pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)

  • 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

  • Corneal abnormalities such as stromal, epithelial, or endothelial dystrophies (e.g., any observed guttata) that are predicted to cause visual acuity losses to a level worse than 0.66 decimal (6/9 or 20/30 Snellen) during the study

  • Irregular corneal astigmatism

  • Inability to achieve keratometric stability for contact lens wearers

  • Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject

  • Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level worse than 0.66 decimal (6/9 or 20/30 Snellen) during the study

  • Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects

  • Use of systemic or ocular medications that may affect vision

  • Prior, current, or anticipated use during the course of the 6-month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery)

  • Poorly controlled diabetes

  • Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcome of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.) Note: Controlled ocular hypertension without glaucomatous changes (optic nerve cupping and visual field loss) is acceptable

  • Known ocular disease or pathology that, in the opinion of the investigator,

  • may affect visual acuity

  • may require surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, uncontrolled glaucoma, etc.)

  • may be expected to require retinal laser treatment or other surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.)

  • Pregnancy, planned pregnancy, presently lactating, or another condition associated with hormonal fluctuation 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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Vision Eye InstituteChatswoodNew South WalesAustralia2067
2George St Eye CentreSydneyNew South WalesAustralia2000
3Sunshine Eye ClinicBirtinyaQueenslandAustralia4575
4Queensland Eye InstituteSouth BrisbaneQueenslandAustralia4101
5Auckland Eye LtdRemueraAucklandNew Zealand1050

Sponsors and Collaborators

  • Johnson & Johnson Surgical Vision, Inc.

Investigators

  • Study Director: Johnson & Johnson Surgical Vision Clinical Trials, Johnson & Johnson Surgical Vision

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johnson & Johnson Surgical Vision, Inc.
ClinicalTrials.gov Identifier:
NCT04890249
Other Study ID Numbers:
  • PCOL-102-AHSF
First Posted:
May 18, 2021
Last Update Posted:
Oct 11, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 11, 2021