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

September 18, 2021 updated by: Yune Zhao, Wenzhou Medical University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325027
        • Ophthalmology and Optometry Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PanOptix
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
All the patients will be bilaterally implanted with PanOptix IOL，one eye will be randomized selected for monocular analysis of each patient.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
capsule bending index（CBI）
Time Frame: 3months
Post-op 1 day，1week，1month，and 3 months monocular CBI(Swept source OCT,Casia SS-1000; Tomey)
3months
lOL tilt
Time Frame: 3 months
Post-op 1 day ,1 week,1 month and 3 months lOL tilt(Swept source OCT,Casia SS-1000; Tomey)
3 months
lOL decentration
Time Frame: 3 months
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）
Time Frame: 3 months
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)
Time Frame: 3 months
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）
Time Frame: 3 months
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)
Time Frame: 3 months
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）
Time Frame: 3 months
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)
Time Frame: 3 months
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
Time Frame: 3 months
Pre-op and post-op 1 day,1 week,1 month and 3 months manifest refraction
3 months
Monocular defocus curve
Time Frame: 3 months
Post-op 1month,3 months monocular defocus curve
3 months
modulation transfer function（MTF）
Time Frame: 3 months
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）
Time Frame: 3 months
Post-op 1 day,1 week,1 month and 3 months HOA(OPD-Scan III Analyzer,NIDEK CO.,LTD.,Tokyo,Japan)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wenzhou Medical University

Investigators

  • Study Chair: yune zhao, MD, Wenzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2021

Primary Completion (Anticipated)

September 30, 2022

Study Completion (Anticipated)

September 30, 2022

Study Registration Dates

First Submitted

August 22, 2021

First Submitted That Met QC Criteria

September 4, 2021

First Posted (Actual)

September 13, 2021

Study Record Updates

Last Update Posted (Actual)

September 21, 2021

Last Update Submitted That Met QC Criteria

September 18, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZYY-PanOptix IOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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