Clinical trial NCT04528069: Clinical Investigation of the Visual Outcomes and Safety of a Trifocal Toric IOL in an Asian Population
Official title: Clinical Investigation of the Visual Outcomes and Safety of AcrySof® IQ PanOptix® Toric Trifocal IOLs in an Asian Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphakia
Corneal Astigmatism
Keywords: Intraocular lens
Cataract
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2020-08-27
Enrollment: 58
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the clinical performance of the ACRYSOF® IQ PanOptix® Toric Trifocal intraocular lens (IOL) when implanted in the eye following cataract removal in an Asian population.

Detailed description: Both eyes will be implanted with the PanOptix Toric Trifocal IOL. The eye with the highest astigmatism will be implanted first. The second eye will be implanted within 7-14 days of the first eye.

Subjects will attend a total of 10 scheduled visits as follows: 1 screening visit, 1 operative visit for each eye, 2 post-operative visits for each eye, and 3 postoperative visits where both eyes will be evaluated. The duration of participation for each subject will be approximately 8 months.

This study will be conducted in Australia.

Eligibility criteria: Key Inclusion Criteria:

* Planned bilateral cataract removal followed by posterior chamber IOL implantation with PanOptix Toric (TFNT30, TFNT40, TFNT50, or TFNT60);
* Calculated target residual refractive error within ±0.50 diopter (D) of emmetropia within the commercially available IOL Power Range in both operative eyes;
* Preoperative regular corneal keratometric astigmatism with predicted residual refractive astigmatism ≤ 0.50 diopter (D) in both operative eyes;
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Preoperative irregular astigmatism;
* Clinically significant corneal abnormalities;
* Glaucoma;
* History of or current retinal disease; anterior or posterior segment inflammation;
* Other planned ocular surgical procedures including, but not limited to, limbal relaxing incision (LRI)/Astigmatic Keratotomy and laser-assisted in situ keratomileusis (LASIK);
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Monocular Residual Manifest Cylinder for All Operative Eyes for All IOL Models Combined
timeFrame: Month 3 postoperative, Month 6 postoperative
measure: Percentage of Eyes With IOL Rotation Less Than 10 Degrees
timeFrame: Month 3 postoperative, Month 6 postoperative
measure: Mean Binocular Best Corrected Distance Visual Acuity (BCDVA)
timeFrame: Month 3 postoperative, Month 6 postoperative
measure: Mean Binocular Distance Corrected Intermediate Visual Acuity (DCIVA)
timeFrame: Month 3 postoperative, Month 6 postoperative
measure: Mean Binocular Distance Corrected Near Visual Acuity (DCNVA)
timeFrame: Month 3 postoperative, Month 6 postoperative
measure: Percentage of Eyes With Secondary Surgical Interventions (SSIs), by Category
timeFrame: Up to Month 6 postoperative
measure: Percentage of Subjects With a Severe Visual Disturbance
timeFrame: Preoperative, Month 3 postoperative, Month 6 postoperative
measure: Percentage of Subjects With a Most Bothersome Visual Disturbance (QUVID)
timeFrame: Preoperative, Month 3 postoperative, Month 6 postoperative
measure: Percentage of Subjects With Ocular Serious Adverse Events Including Serious Adverse Device Effects
timeFrame: Up to Month 6 postoperative
measure: Percentage of Subjects With Nonocular Serious Adverse Events Including Serious Adverse Device Effects
timeFrame: Up to Month 6 postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Campsie
country: Australia
facility: Alcon Investigator 8117
state: New South Wales
city: Sydney
country: Australia
facility: Alcon Investigator 7678
state: New South Wales
city: Footscray
country: Australia
facility: Alcon Investigator 7813
state: Victoria
city: Saint Albans
country: Australia
facility: Alcon Investigator 8122
state: Victoria
Study officials:
affiliation: Alcon Research, LLC
name: Sr. Clinical Trial Lead, CDMA Surgical
role: STUDY_DIRECTOR
References: