Prospective Evaluation and Comparison of Bilateral Synergy Implants and Bilateral PanOptix Implants

Cataract Clinical Trial

Official title:

Prospective Evaluation and Comparison of Bilateral Synergy Implants and Bilateral PanOptix Implants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05186298
• Other study ID #: 68985013
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2021
• Est. completion date: May 2022

Study information

• Verified date: January 2022
• Source: Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons
• Contact: Satish S Modi, MD
• Phone: 845-454-1025
• Email: smodieyes[@]aol.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the AcrySof PanOptix Intraocular Lens (IOL) for binocular distance corrected near visual acuity (DCNVA) compared to TECNIS Synergy IOL.

Presbyopia correcting diffractive intraocular implants (extended depth of focus, multifocal, and trifocal) provide cataract and refractive surgeons with an effective treatment means for allowing patients to experience increased spectacle independence post-cataract surgery.

Description:

Eligible test subjects will be patients diagnosed with cataracts bilaterally who are interested and eligible for implantation of a presbyopia-correcting multifocal intraocular lenses.

Subjects will participate in ten study visits. Visits will include a screening visit (both eyes evaluated), one operative visit for each eye, and 7 postoperative visits. Both eyes will be implanted, with the second eye surgery occurring X (depends on the patient and the schedule) days after the first.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

Note: Ocular criteria must be met in both eyes.

• are willing and able to understand and sign an informed consent;

• are willing and able to attend all study visits;

• Subjects diagnosed with bilateral cataracts with planned cataract removal by femto assisted phacoemulsification with a clear corneal incision and intraoperative aberrometry assisted

• Clear intraocular media other than cataracts.

• Projected BCDVA of better than 0.10 logMAR.

• Preoperative regular keratometric astigmatism (by biometer) of less than or equal to 0.75D, in both eyes

• Biometer IOL calculations within +6.0 - +30.0 power range

Exclusion Criteria:

If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

• Clinically significant corneal abnormality, irregularity, inflammation, or edema aberrations, corneal disease, degeneration, or conditions affecting postoperative visual acuity

• Glaucoma or Ocular Hypertension

• Planned multiple procedures (eg MIGS)

• Amblyopia, Strabismus

• Patient's IOL calculation that are outside the range of available lenses

• Prior corneal refractive surgery or other corneal surgery (e.g., corneal transplant, lamellar keratoplasty, LASIK, PRK)

• Previous anterior or posterior chamber surgery (e.g., vitrectomy) that the investigator feels may compromise visual outcomes

• Diabetic retinopathy if the investigator feels this will compromise visual outcomes

• Macular Pathology (i.e., ERM, ARMD, DMR etc.) if the investigator feels this will compromise visual outcomes

• History of retinal detachment

• If, in the surgeon's opinion, the subject is not an appropriate candidate for multifocal IOL implantation (eg. patients who are professional night drivers or pilots, and those with other occupations for whom induces dysphotopsias could put their career at risk)

• Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect post-operative visual acuity.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• AcrySof® IQ PanOptix®
The AcrySof IQ PanOptix® (Alcon) mitigates the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity with a reduced need for eyeglasses, compared to a monofocal IOL
• Synergy®
The TECNIS Synergy™ IOLs mitigate the effects of presbyopia by providing far vision comparable to an aspheric monofocal IOL. Compared to an aspheric monofocal IOL, the lens provides significantly improved intermediate and near vision, including in low-light conditions.

Procedure:
• Cataract Surgery
IOL implantation will be performed

Locations

Country	Name	City	State
United States	Eye Care Specialists	Kingston	Pennsylvania
United States	Lehmann Eye Center	Nacogdoches	Texas
United States	Eye Care Now	Panama City	Florida
United States	Seeta Eye Center	Poughkeepsie	New York
United States	Northwest Eye Surgeons	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binocular DCNVA	Binocular DCNVA of Trifocal (Alcon Panoptix) versus EDOF/Bifocal (Johnson and Johnson Tecnis Synergy) at 40 cm	Up to Month 6
Secondary	Visual Disturbances Evaluation	Patient reported occurrences of visual disturbances of each group (unsolicited) at all visits	at all visits
Secondary	Visual Disturbances Evaluation by Questionnaire (QUVID)	Patient reported visual disturbances by questionnaire (QUVID) postop	Up to Month 6
Secondary	BCDVA and DCIVA (60 cm)	Monocular and binocular BCDVA and DCIVA (60 cm) in both groups will be measured	Up to Month 6
Secondary	DCNVA (40 cm)	Monocular DCNVA (40 cm) in both groups will be measured	Up to Month 6
Secondary	Uncorrected Monocular and Binocular VA	Uncorrected monocular and binocular VA at distance, intermediate (60 cm) and near (40 cm)	Up to Month 6
Secondary	Visual Disturbances Evaluation by Questionnaire (IOL SAT)	Patient satisfaction of each group by questionnaire (IOL SAT) postop	Up to Month 6
Secondary	Defocus Curve	Defocus curve tested in binocular photopic conditions (+1.00 to -3.00 in 0.50D except +0.50 to -0.50 in 0.25D)	Up to Month 6