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Tecnis ZLB00 & Symfony Intraocular Lens Combination Outcomes

Primary Purpose

Cataract Bilateral, Presbyopia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Tecnis ZLB00 & Symfony IOL

About this trial

This is an interventional treatment trial for Cataract Bilateral

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject is undergoing bilateral cataract extraction with intraocular lens implantation.
Willing and able to provide written informed consent for participation in the study
Willing and able to comply with scheduled visits and other study procedures.
Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6-15 days between surgeries.
Subjects who require an IOL power in the range of +5.0 D to +34.0 D only.
Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.

Exclusion Criteria:

Contraindication for a presbyopia correcting IOL.
Subjects with severe astigmatism in the non-dominant eye
Uncontrolled diabetes.
Use of any systemic or topical drug known to interfere with visual performance.
Contact lens use during the active treatment portion of the trial.
Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
Clinically significant corneal dystrophy
History of chronic intraocular inflammation.
History of retinal detachment.
Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
Previous intraocular surgery.
Previous refractive surgery.
Previous keratoplasty
Severe dry eye
Pupil abnormalities
Subject who may reasonably be expected to require a secondary surgical intervention at any time during the study (other than yttrium aluminum garnet (YAG) capsulotomy, i.e. LASIK)
Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc).
Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results.
Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.

Sites / Locations

Carolina Eyecare Physicians, LLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tecnis ZLB00 & Symfony IOL

Arm Description

The Tecnis multifocal ZLB00 and the Symfony IOLs are presbyopia correcting lenses designed to improve the vision at distance, intermediate and near reducing the need for glasses in patients undergoing cataract surgery.

Outcomes

Primary Outcome Measures

Binocular Uncorrected Near (40 cm) Visual Acuity.

Visual acuity measured at 40 cm without wearing any correction.

Secondary Outcome Measures

Patient Visual Satisfaction After Cataract Surgery: Questionnaire

Patient's overall satisfaction with their vision after cataract surgery assessed by asking the following question: "Taking all things into account, how satisfied or dissatisfied are you with your vision WITHOUT glasses or contacts with your near vision". Possible answers are: Completely satisfied and mostly satisfied, moderately satisfied, a little satisfied or not at all satisfied.

Spectacle Independence: Questionnaire

Patient's spectacle independence was assessed using the "Patient Reported Spectacle Independence Questionnaire (PRSIQ) which includes the following questions: 1. During the LAST 7 DAYS, did you need glasses or contacts for near. Possible answers: Yes No.

Number of Participants With Visual Symptoms

Number of participants who reported any visual disturbances or symptoms. One participant could report more than one symptom.

Full Information

NCT ID

NCT03771274

First Posted

December 5, 2018

Last Updated

August 6, 2020

Sponsor

Carolina Eyecare Physicians, LLC

Collaborators

Science in Vision, Johnson & Johnson Surgical Vision, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03771274

Brief Title

Tecnis ZLB00 & Symfony Intraocular Lens Combination Outcomes

Official Title

Visual Outcomes of an Extended Depth of Focus (EDOF) Intraocular Lens (IOL) Combined With a Multifocal (MF) IOL

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

December 7, 2018 (Actual)

Primary Completion Date

October 31, 2019 (Actual)

Study Completion Date

October 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Carolina Eyecare Physicians, LLC

Collaborators

Science in Vision, Johnson & Johnson Surgical Vision, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

Current visual outcomes expectations of cataract patients are similar to those of refractive surgery patients. Their desire is to be spectacle independent for far, intermediate and near vision activities. Some may have already enjoyed freedom from glasses and would like to continue after the cataracts are removed. Different options are available. These options include: mono-vision and presbyopia correcting intraocular lenses (IOL). Presbyopia correcting IOLs include accommodative, multifocals and extended depth of focus (EDOF) IOLs. In a previous study, the visual outcomes of the EDOF Toric IOL were evaluated when both eyes were targeted for plano and when the non-dominant eye was set for a small residual myopic error (-0.50 D) or nanovision in patients with astigmatism. The nanovision approach, appeared to provide similar binocular acuity at distance and intermediate but better acuity at near. The purpose of this study is to evaluate the visual outcomes of an EDOF IOL when combined with a multifocal IOL with a +3.25 D add in patients with or without astigmatism undergoing routine cataract surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract Bilateral, Presbyopia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tecnis ZLB00 & Symfony IOL

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Tecnis ZLB00 & Symfony IOL

Intervention Description

The Symfony IOL will be implanted in the dominant eye while the Tecnis ZLB00 will be implanted in the non-dominant eye.

Primary Outcome Measure Information:

Title

Binocular Uncorrected Near (40 cm) Visual Acuity.

Description

Visual acuity measured at 40 cm without wearing any correction.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Patient Visual Satisfaction After Cataract Surgery: Questionnaire

Description

Time Frame

3 months

Title

Spectacle Independence: Questionnaire

Description

Time Frame

3 months

Title

Number of Participants With Visual Symptoms

Description

Number of participants who reported any visual disturbances or symptoms. One participant could report more than one symptom.

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject is undergoing bilateral cataract extraction with intraocular lens implantation. Willing and able to provide written informed consent for participation in the study Willing and able to comply with scheduled visits and other study procedures. Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6-15 days between surgeries. Subjects who require an IOL power in the range of +5.0 D to +34.0 D only. Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes. Exclusion Criteria: Contraindication for a presbyopia correcting IOL. Subjects with severe astigmatism in the non-dominant eye Uncontrolled diabetes. Use of any systemic or topical drug known to interfere with visual performance. Contact lens use during the active treatment portion of the trial. Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis. Clinically significant corneal dystrophy History of chronic intraocular inflammation. History of retinal detachment. Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules. Previous intraocular surgery. Previous refractive surgery. Previous keratoplasty Severe dry eye Pupil abnormalities Subject who may reasonably be expected to require a secondary surgical intervention at any time during the study (other than yttrium aluminum garnet (YAG) capsulotomy, i.e. LASIK) Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc). Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results. Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.

Facility Information:

Facility Name

Carolina Eyecare Physicians, LLC

City

Mount Pleasant

State/Province

South Carolina

ZIP/Postal Code

29464

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Tecnis ZLB00 & Symfony Intraocular Lens Combination Outcomes

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