Status:
COMPLETED
Post-Market Clinical Study of the PanOptix Intraocular Lens (IOL) in a Chinese Population
Lead Sponsor:
Alcon Research
Conditions:
Aphakia
Presbyopia
Eligibility:
All Genders
18+ years
Phase:
NA
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, incl...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
April 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2023
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT04755231
Start Date
April 19 2021
End Date
March 15 2023
Last Update
October 10 2023
Active Locations (9)
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1
Peking University People's Hospital
Beijing, China, 100044
2
Beijing Tongren Hospital Capital Medical University
Beijing, China, 100730
3
Zhongshan Ophthalmic Center, Sun Yat-Sen University
Guandong, China, 510060
4
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China, 310009