To Evaluate IOL Position, Clinical Outcome of PanOptix in High Myopic Cataract Patients

Study Overview
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Brief Summary
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To evaluate IOL position, clinical outcome of PanOptix in high myopic cataract patients

Detailed Description
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A prospective, single center study to evaluate IOL position, clinical outcome of PanOptix in high myopic cataract patients. The objective of this study to investigate the refractive and visual performance of PanOptix and explore their correlation with ELP change, capsular bending formation, IOL tilt/decentration in high myopic cataract patients. PanOptix IOL provides good refractive outcomes and visual quality because of few ELP change, fast capsular bending formation and few tilt and decentration in high myopic cataract patients.

Official Title
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A Prospective, Single Center Study to Evaluate IOL Position, Clinical Outcome of PanOptix in High Myopic Cataract Patients

Conditions
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Cataract, High Myopia

Intervention / Treatment
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* Procedure: PanOptix IOL implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 years old 26 ≤Axial length<30mm, IOL power ≥6D (PanOptix IOL power is available +6D-+30D ) Eyes with corneal astigmatism less than 1.0D (IOLMaster 700, Carl Zeiss Meditec AG) Eyes with pupil diameter between 3 and 5.5 mm (iTrace, Tracey Technology, Houston, Texas, USA) Eyes with angle kappa and angle Alpha ≤0.50 mm (iTrace); Eyes with corneal spherical aberration ≤ 0.50 (Pentacam). Exclusion Criteria: Irregular corneal astigmatism Serious intraoperative complications, glaucoma, pseudoexfoliation syndrome, uveitis, macular degeneration or other retinal impairment Moderate-severe dry eye, corneal scarring, amblyopia Patients who can't cooperate with post-op 3 months follow-up.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PanOptix<br>All the patients will be bilaterally implanted with PanOptix IOL，one eye will be randomized selected for monocular analysis of each patient. | Procedure: PanOptix IOL implantation<br>* All the patients will be bilaterally implanted with PanOptix IOL，one eye will be randomized selected for monocular analysis of each patient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective Lens Position（ELP） | Mean change of ELP for 3 months | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| capsule bending index（CBI） | Post-op 1 day，1week，1month，and 3 months monocular CBI(Swept source OCT,Casia SS-1000; Tomey) | 3months | 
| lOL tilt | Post-op 1 day ,1 week,1 month and 3 months lOL tilt(Swept source OCT,Casia SS-1000; Tomey) | 3 months | 
| lOL decentration | Post-op 1 day ,1 week,1 month and 3 months lOL decentration(Swept source OCT,Casia SS-1000; Tomey) | 3 months | 
| Monocular uncorrected distance visual acuity（UDVA） | Pre-op and post-op 1 day,1 week,1 month and 3 months Monocular UDVA(Chinese standard logarithmic charts) | 3 months | 
| Monocular best corrected distance visual acuity（BCDVA）(5m) | Pre-op and post-op 1 day,1 week,1 month and 3 months Monocular BCDVA(5m)(Chinese standard logarithmic charts) | 3 months | 
| Monocular uncorrected intermediate visual acuity（UIVA） | Pre-op and post-op 1 day,1 week,1 month and 3 months Monocular UIVA(Chinese standard logarithmic charts) | 3 months | 
| Monocular distance corrected intermediate visual acuity(DCIVA)(60cm) | Pre-op and post-op 1 day,1 week,1 month and 3 months Monocular DCIVA(60cm)(Chinese standard logarithmic charts) | 3 months | 
| Monocular uncorrected near visual acuity（UNVA） | Pre-op and post-op 1 day,1 week,1 month and 3 months Monocular UNVA(Chinese standard logarithmic charts) | 3 months | 
| Monocular distance corrected near visual acuity(DCNVA)(40cm) | Pre-op and post-op 1 day,1 week,1 month and 3 months Monocular DCNVA(40cm)(Chinese standard logarithmic charts) | 3 months | 
| manifest refraction | Pre-op and post-op 1 day,1 week,1 month and 3 months manifest refraction | 3 months | 
| Monocular defocus curve | Post-op 1month,3 months monocular defocus curve | 3 months | 
| modulation transfer function（MTF） | Post-op 1 day,1 week,1 month and 3 months MTF(OPD-Scan III Analyzer,NIDEK CO.,LTD.,Tokyo,Japan) | 3 months | 
| high-order aberrations（HOA） | Post-op 1 day,1 week,1 month and 3 months HOA(OPD-Scan III Analyzer,NIDEK CO.,LTD.,Tokyo,Japan) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PanOptix IOL, high myopic cataract patients