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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05042856
• Other study ID #: ZYY-PanOptix IOL
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: September 2021
• Source: Wenzhou Medical University
• Contact: yinying zhao
• Phone: +86 13957763247
• Email: ginger146[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• High Myopia

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	Ophthalmology and Optometry Hospital	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective Lens Position(ELP)	Mean change of ELP for 3 months	3 months
Secondary	capsule bending index(CBI)	Post-op 1 day,1week,1month,and 3 months monocular CBI(Swept source OCT,Casia SS-1000; Tomey)	3months
Secondary	lOL tilt	Post-op 1 day ,1 week,1 month and 3 months lOL tilt(Swept source OCT,Casia SS-1000; Tomey)	3 months
Secondary	lOL decentration	Post-op 1 day ,1 week,1 month and 3 months lOL decentration(Swept source OCT,Casia SS-1000; Tomey)	3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	manifest refraction	Pre-op and post-op 1 day,1 week,1 month and 3 months manifest refraction	3 months
Secondary	Monocular defocus curve	Post-op 1month,3 months monocular defocus curve	3 months
Secondary	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
Secondary	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