N/A
N=144
Post-Market Clinical Study of the PanOptix Intraocular Lens (IOL) in a Chinese Population
Aphakia · Presbyopia
Bottom Line
View on ClinicalTrials.gov: NCT04755231 ↗Enrolled (actual)
144
Serious AEs
1.9%
Results posted
Oct 2023
Primary outcome: Primary: Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) Equal to or Better Than 0.3 LogMAR - Monocular — 100; 98.5; 99.3 percentage of eyes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AcrySof IQ PanOptix Presbyopia Correcting IOL (Device); Cataract surgery (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) Equal to or Better Than 0.3 LogMAR - Monocular |
100; 98.5; 99.3 | — |
| PRIMARY Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) Equal to or Better Than 0.3 LogMAR - Binocular |
100 | — |
| PRIMARY Mean Best Corrected Distance Visual Acuity (BCDVA) - Monocular |
-0.02; -0.02; -0.02 | — |
| PRIMARY Mean Best Corrected Distance Visual Acuity (BCDVA) - Binocular |
-0.08 | — |
| PRIMARY Mean Distance Corrected Intermediate Visual Acuity (DCIVA) - Monocular |
0.073; 0.072; 0.073 | — |
| PRIMARY Mean Distance Corrected Intermediate Visual Acuity (DCIVA) - Binocular |
0.018 | — |
| PRIMARY Mean Distance Corrected Near Visual Acuity (DCNVA) - Monocular |
0.082; 0.078; 0.080 | — |
| PRIMARY Mean Distance Corrected Near Visual Acuity (DCNVA) - Binocular |
0.025 | — |
| PRIMARY Number of Ocular Treatment Emergent Adverse Events |
37; 33; 70 | — |
| PRIMARY Number of Non-Ocular Treatment Emergent Adverse Events |
28 | — |
| PRIMARY Number of Secondary Surgical Interventions |
0; 0; 0 | — |
| PRIMARY Number of Participants Reporting a Severe Visual Disturbance (QUVID) |
13; 21; 9; 6; 6; 3 | — |
| PRIMARY Number of Participants Reporting a Most Bothersome Visual Disturbance (QUVID) |
2; 2; 3; 2; 4; 2 | — |
Summary
The primary objective of this clinical study is to assess the clinical performance of the PanOptix IOL in a Chinese population.
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.
Data sourced from ClinicalTrials.gov (NCT04755231). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.