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

Not Applicable

• Conditions: High Myopia; Cataract
• Interventions: Procedure: PanOptix IOL implantation

• Registration Number: NCT05042856
• Lead Sponsor: Wenzhou Medical University

Brief Summary

To evaluate IOL position, clinical outcome of PanOptix in high myopic cataract patients

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-08-22
• Status Verified: 2021-09
• Study First Submitted QC: 2021-09-04
• Study First Posted: 2021-09-13
• Last Update Submitted: 2021-09-18
• Last Update Posted: 2021-09-21
• Study Start: 2021-10-01
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PanOptix	PanOptix IOL implantation	All the patients will be bilaterally implanted with PanOptix IOL，one eye will be randomized selected for monocular analysis of each patient.

Primary Outcome Measures

Name	Time	Method
Effective Lens Position（ELP）	3 months	Mean change of ELP for 3 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ophthalmology and Optometry Hospital; 🇨🇳 Wenzhou, Zhejiang, China