Clinical trial NCT04755231: Post-Market Clinical Study of the PanOptix Intraocular Lens (IOL) in a Chinese Population
Official title: Post-Market Clinical Study of the AcrySof® IQ PanOptix® Presbyopia Correcting Intraocular Lens in a Chinese Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphakia
Presbyopia
Keywords: Cataract
Intraocular Lens
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2021-02-16
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this clinical study is to assess the clinical performance of the PanOptix IOL in a Chinese population.

Detailed description: In this clinical study, subjects will be implanted with the PanOptix IOL in both eyes. The second eye surgery will occur 7-28 days after the first eye. A total of 11 scheduled visits are planned, including a screening visit, two operative visits, and 8 postoperative visits. The total expected duration of the subject's participation will be about 14 months. This study will be conducted in China.

Eligibility criteria: Key Inclusion Criteria:

* Able to comprehend and sign an informed consent form;
* Able to complete all study visits required in the protocol;
* Chinese; diagnosed with cataracts in both eyes;
* Planned bilateral cataract removal by routine phacoemulsification;
* Pre-operative regular corneal astigmatism of less than 1.0 diopter (D);
* Pre-operative best corrected distance visual acuity (BCDVA) worse than or equal to 0.3 LogMAR in each eye;
* Potential postoperative best corrected distance visual acuity (BCDVA) of 0.3 logMAR or better in both eyes based on the investigator expert medical opinion.
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Glaucoma, diabetic retinopathy, retinitis pigmentosa and any pathologic changes associated with the optic nerve;
* Clinically significant corneal diseases;
* Clinically significant/severe dry eye that would affect study measurements based on the investigator's expert medical opinion;
* Previous intraocular or corneal surgery;
* Pregnancy or lactation during study or planning to be pregnant/lactating;
* Systemic medications that, in the opinion of the Investigator, may confound the outcome or increase the risk to the subject;
* Other planned ocular surgical procedures;
* Patients who desire monovision correction.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) Equal to or Better Than 0.3 LogMAR - Monocular
timeFrame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
measure: Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) Equal to or Better Than 0.3 LogMAR - Binocular
timeFrame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
measure: Mean Best Corrected Distance Visual Acuity (BCDVA) - Monocular
timeFrame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
measure: Mean Best Corrected Distance Visual Acuity (BCDVA) - Binocular
timeFrame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
measure: Mean Distance Corrected Intermediate Visual Acuity (DCIVA) - Monocular
timeFrame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
measure: Mean Distance Corrected Intermediate Visual Acuity (DCIVA) - Binocular
timeFrame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
measure: Mean Distance Corrected Near Visual Acuity (DCNVA) - Monocular
timeFrame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
measure: Mean Distance Corrected Near Visual Acuity (DCNVA) - Binocular
timeFrame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
measure: Number of Ocular Treatment Emergent Adverse Events
timeFrame: Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery)
measure: Number of Non-Ocular Treatment Emergent Adverse Events
timeFrame: Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery)
measure: Number of Secondary Surgical Interventions
timeFrame: Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery)
measure: Number of Participants Reporting a Severe Visual Disturbance (QUVID)
timeFrame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery); Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery)
measure: Number of Participants Reporting a Most Bothersome Visual Disturbance (QUVID)
timeFrame: Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery); Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery)
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital Capital Medical University
city: Guandong
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-Sen University
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
city: Peking
country: China
facility: Peking University People's Hospital
city: Shandong
country: China
facility: Ophthalmic Hospital Affiliated to Shandong University of Traditional Chinese Medicine
city: Shanghai
country: China
facility: Eye & ENT Hospital of Fudan University
city: Shanxi
country: China
facility: Shanxi Eye Hospital
city: Sichuan
country: China
facility: West China Hospital of Sichuan University
city: Tianjin
country: China
facility: Tianjin Medical University Eye Hospital
Study officials:
affiliation: Alcon (China) Ophthalmic Product Co., Ltd.
name: Sr. Clinical Project Manager, Surgical
role: STUDY_DIRECTOR
References: