Tecnis ZLB00 & Symfony Intraocular Lens Combination Outcomes

• Sponsor: Carolina Eyecare Physicians, LLC (Other)
• Overall Status: Completed
• CT.gov ID: NCT03771274
• Collaborator: Science in Vision (Other), Johnson & Johnson Surgical Vision, Inc. (Industry)
• Enrollment: 39
• Location: 1
• Arm: 1
• Actual Duration (Months): 10.8
• Patients Per Site Per Month: 3.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract Bilateral; Presbyopia	Device: Tecnis ZLB00 & Symfony IOL	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Visual Outcomes of an Extended Depth of Focus (EDOF) Intraocular Lens (IOL) Combined With a Multifocal (MF) IOL
• Actual Study Start Date: Dec 7, 2018
• Actual Primary Completion Date: Oct 31, 2019
• Actual Study Completion Date: Oct 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tecnis ZLB00 & Symfony IOL 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.	Device: Tecnis ZLB00 & Symfony IOL; The Symfony IOL will be implanted in the dominant eye while the Tecnis ZLB00 will be implanted in the non-dominant eye.

Outcome Measures

Primary Outcome Measures

1. Binocular Uncorrected Near (40 cm) Visual Acuity. [3 months]

   Visual acuity measured at 40 cm without wearing any correction.

Secondary Outcome Measures

1. Patient Visual Satisfaction After Cataract Surgery: Questionnaire [3 months]

   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.

2. Spectacle Independence: Questionnaire [3 months]

   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.

3. Number of Participants With Visual Symptoms [3 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject is undergoing bilateral cataract extraction with intraocular lens implantation.

2. Willing and able to provide written informed consent for participation in the study

3. Willing and able to comply with scheduled visits and other study procedures.

4. Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6-15 days between surgeries.

5. Subjects who require an IOL power in the range of +5.0 D to +34.0 D only.

6. Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.

Exclusion Criteria:

1. Contraindication for a presbyopia correcting IOL.

2. Subjects with severe astigmatism in the non-dominant eye

3. Uncontrolled diabetes.

4. Use of any systemic or topical drug known to interfere with visual performance.

5. Contact lens use during the active treatment portion of the trial.

6. Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.

7. Clinically significant corneal dystrophy

8. History of chronic intraocular inflammation.

9. History of retinal detachment.

10. Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.

11. Previous intraocular surgery.

12. Previous refractive surgery.

13. Previous keratoplasty

14. Severe dry eye

15. Pupil abnormalities

16. 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)

17. Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc).

18. 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.

19. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Carolina Eyecare Physicians, LLC	Mount Pleasant	South Carolina	United States	29464

Sponsors and Collaborators

• Carolina Eyecare Physicians, LLC
• Science in Vision
• Johnson & Johnson Surgical Vision, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 23, 2018

More Information

Publications

None provided.

• Responsible Party: Carolina Eyecare Physicians, LLC
• ClinicalTrials.gov Identifier: NCT03771274
• Other Study ID Numbers: CEP18-002
• First Posted: Dec 11, 2018
• Last Update Posted: Aug 10, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Cataract; Presbyopia

Study Results

Participant Flow

Arm/Group Title	Tecnis ZLB00 & Symfony IOL
Arm/Group 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. Tecnis ZLB00 & Symfony IOL: The Symfony IOL will be implanted in the dominant eye while the Tecnis ZLB00 will be implanted in the non-dominant eye.
Period Title: Overall Study
STARTED	39
COMPLETED	39
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Tecnis ZLB00 & Symfony IOL
Arm/Group 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. Tecnis ZLB00 & Symfony IOL: The Symfony IOL will be implanted in the dominant eye while the Tecnis ZLB00 will be implanted in the non-dominant eye.
Overall Participants	39
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.7 (6.2)
Sex: Female, Male (Count of Participants)
Female	22 56.4%
Male	17 43.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 2.6%
Not Hispanic or Latino	38 97.4%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 2.6%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	38 97.4%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Binocular Uncorrected Near (40 cm) Visual Acuity.
Description	Visual acuity measured at 40 cm without wearing any correction.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tecnis ZLB00 & Symfony IOL
Arm/Group 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. Tecnis ZLB00 & Symfony IOL: The Symfony IOL will be implanted in the dominant eye while the Tecnis ZLB00 will be implanted in the non-dominant eye.
Measure Participants	39
Mean (Standard Deviation) [logMAR]	0.13 (0.09)

2. Secondary Outcome

Title	Patient Visual Satisfaction After Cataract Surgery: Questionnaire
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tecnis ZLB00 & Symfony IOL
Arm/Group 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. Tecnis ZLB00 & Symfony IOL: The Symfony IOL will be implanted in the dominant eye while the Tecnis ZLB00 will be implanted in the non-dominant eye.
Measure Participants	39
Completely or mostly satisfied	27 69.2%
Moderately satisfied	5 12.8%
A little or not satisfied	7 17.9%

3. Secondary Outcome

Title	Spectacle Independence: Questionnaire
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tecnis ZLB00 & Symfony IOL
Arm/Group 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. Tecnis ZLB00 & Symfony IOL: The Symfony IOL will be implanted in the dominant eye while the Tecnis ZLB00 will be implanted in the non-dominant eye.
Measure Participants	39
Yes	12 30.8%
No	27 69.2%

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tecnis ZLB00 & Symfony IOL
Arm/Group 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. Tecnis ZLB00 & Symfony IOL: The Symfony IOL will be implanted in the dominant eye while the Tecnis ZLB00 will be implanted in the non-dominant eye.
Measure Participants	39
Halos : Yes	25 64.1%
Halos : No	14 35.9%
Sensitivity to light: Yes	23 59%
Sensitivity to light: No	16 41%

Adverse Events

Time Frame	3 to 5 months
Adverse Event Reporting Description	Adverse events were collected from the moment participant signed the informed consent until he or she exited the study.
Arm/Group Title	Tecnis ZLB00 & Symfony IOL
Arm/Group 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. Tecnis ZLB00 & Symfony IOL: The Symfony IOL will be implanted in the dominant eye while the Tecnis ZLB00 will be implanted in the non-dominant eye.
All Cause Mortality
	Tecnis ZLB00 & Symfony IOL
	Affected / at Risk (%)	# Events
Total	0/39 (0%)
Serious Adverse Events
	Tecnis ZLB00 & Symfony IOL
	Affected / at Risk (%)	# Events
Total	0/39 (0%)
Other (Not Including Serious) Adverse Events
	Tecnis ZLB00 & Symfony IOL
	Affected / at Risk (%)	# Events
Total	0/39 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.