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

NCT ID: NCT05042856

Last Updated: 2021-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-09-30

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.

Conditions

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Cataract High Myopia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PanOptix

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

Group Type EXPERIMENTAL

PanOptix IOL implantation

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Yune Zhao

Vice president of Eye Hospital of Wenzhou Medical University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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yune zhao, MD

Role: STUDY_CHAIR

Wenzhou Medical University

Locations

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Ophthalmology and Optometry Hospital

Wenzhou, Zhejiang, China

Site Status

Countries

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China

Central Contacts

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yinying zhao

Role: CONTACT

+86 13957763247

Facility Contacts

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zhao yun-e

Role: primary

+86 13819707056

Other Identifiers

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ZYY-PanOptix IOL

Identifier Type: -

Identifier Source: org_study_id

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