Clinical trial NCT03771274: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cataract Bilateral
Presbyopia
Lead sponsor: Carolina Eyecare Physicians, LLC
Sponsor class: OTHER
Collaborators: name: Science in Vision
name: Johnson & Johnson Surgical Vision, Inc.
First posted: 2018-12-11
Enrollment: 39
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Binocular Uncorrected Near (40 cm) Visual Acuity.
timeFrame: 3 months
Secondary outcomes:
measure: Patient Visual Satisfaction After Cataract Surgery: Questionnaire
timeFrame: 3 months
measure: Spectacle Independence: Questionnaire
timeFrame: 3 months
measure: Number of Participants With Visual Symptoms
timeFrame: 3 months
Other outcomes:
Locations:
city: Mount Pleasant
country: United States
facility: Carolina Eyecare Physicians, LLC
state: South Carolina
Study officials:
References: