Symfony Toric Intraocular Lens Visual Outcomes

Astigmatism Bilateral Clinical Trial

Official title:

Visual Outcomes of an Extended Depth of Focus (EDOF) Intraocular Lens (IOL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03082599
• Other study ID #: CEP 2016-002
• Status: Completed
• Phase: N/A
• Start date: February 17, 2017
• Est. completion date: April 3, 2018

Study information

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

Clinical Trial Summary

In July 2016, the FDA approved an extended depth of focus (EDOF) IOL (Tecnis Symfony, Abbott Medical Optics) helping to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery. It is available in both a non-toric version and a toric version for patients with astigmatism. The difference between this lens and the multifocal (MIOL) counterpart is that the EDOF, similarly to a monofocal IOL, has one focal point (elongated in the EDOF) while the multifocals have 2 focal points; therefore, having less of a halo and glare problem. Pivotal trial results where Symfony was compared to a monofocal IOL showed similar uncorrected distance visual acuity (UCDVA), better intermediate (77% vs. 34% 20/25 uncorrected intermediate visual acuity - UCIVA) and near vision (Symfony patients were able to read two additional, progressively smaller lines compared to the monofocal IOL).A One potential disadvantage of the EDOF IOL compared to a MIOL is the visual performance at near.B One option to deal with this potential shortcoming is to set the non-dominant eye for a small residual myopic error (-0.50 D)C what is referred to as nano-vision or mini mono-vision.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 3, 2018
• Est. primary completion date: April 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 99 Years

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. Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.

2. Uncontrolled diabetes.

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

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

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

6. Clinically significant corneal dystrophy

7. History of chronic intraocular inflammation.

8. History of retinal detachment.

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

10. Previous intraocular surgery.

11. Previous refractive surgery.

12. Previous keratoplasty

13. Severe dry eye

14. Pupil abnormalities

15. 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)

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

17. 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.

18. 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

• Astigmatism
• Astigmatism Bilateral
• Cataract
• Cataract Bilateral

Intervention

Device:
• Presbyopia and astigmatism correcting intraocular lens
The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.

Locations

Country	Name	City	State
United States	Ophthalmic Consultants of Long Island	Garden City	New York
United States	Slade & Baker Vision Center	Houston	Texas
United States	Carolina Eyecare Physicians, LLC	Mount Pleasant	South Carolina
United States	Associated Eye Care	Stillwater	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Carolina Eyecare Physicians, LLC	Abbott Medical Optics, Science in Vision

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Residual Mean Spherical Equivalent Refraction		3 months
Other	Residual Refractive Sphere		3 months
Other	Residual Refractive Cylinder		3 months
Other	Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Accuracy to Target = 0.5D		3 months
Primary	Binocular Distance-corrected Near (40 cm) Visual Acuity.	Visual acuity with correction (glasses) measured at 40 cm.	3 months
Primary	Reduction of Manifest Cylinder (Diopters).		3 months
Secondary	Uncorrected Near (40 cm) Visual Acuity	Visual acuity without correction (no glasses) measured at 40 cm.	3 months
Secondary	Uncorrected Intermediate (66 cm) Visual Acuity	Visual acuity without correction (no glasses) measured at 66 cm.	3 months
Secondary	Uncorrected (4 m) Visual Acuity	Visual acuity without correction (no glasses) measured at 4 m.	3 months
Secondary	Modified Patient-Reported Visual Symptoms Questionnaire (PRVSQ)	Percentage of patients who reported any visual symptoms such as halos, glare, starburst, light sensitivity when answering the self administered questionnaire.	3 months
Secondary	Patient Reported Spectacle Independence Questionnaire	Percentage of participants who reported wearing glasses none or a little of the time in the self administered questionnaire.	3 months