Tecnis ZLB00 & Symfony Intraocular Lens Combination Outcomes

Presbyopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03771274
• Other study ID #: CEP18-002
• Status: Completed
• Phase: N/A
• Start date: December 7, 2018
• Est. completion date: October 31, 2019

Study information

• Verified date: August 2020
• Source: Carolina Eyecare Physicians, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Cataract Bilateral
• Presbyopia

Intervention

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.

Locations

Country	Name	City	State
United States	Carolina Eyecare Physicians, LLC	Mount Pleasant	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Carolina Eyecare Physicians, LLC	Johnson & Johnson Surgical Vision, Inc., Science in Vision

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binocular Uncorrected Near (40 cm) Visual Acuity.	Visual acuity measured at 40 cm without wearing any correction.	3 months
Secondary	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.	3 months
Secondary	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.	3 months
Secondary	Number of Participants With Visual Symptoms	Number of participants who reported any visual disturbances or symptoms. One participant could report more than one symptom.	3 months