Tecnis ZLB00 & Symfony Intraocular Lens Combination Outcomes
| Status: | Recruiting |
|---|---|
| Conditions: | Ocular, Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 2/1/2019 |
| Start Date: | December 7, 2018 |
| End Date: | March 31, 2020 |
| Contact: | Helga P Sandoval, MD, MSCR |
| Email: | helga.sandoval@carolinaeyecare.com |
| Phone: | 8438813937 |
Visual Outcomes of an Extended Depth of Focus (EDOF) Intraocular Lens (IOL) Combined With a Multifocal (MF) IOL
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.
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.
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.
We found this trial at
1
site
Click here to add this to my saved trials
