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

Primary Purpose

Cataract, High Myopia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PanOptix IOL implantation
Sponsored by
Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring PanOptix IOL, high myopic cataract patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ophthalmology and Optometry Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PanOptix

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

capsule bending index（CBI）
Post-op 1 day，1week，1month，and 3 months monocular CBI(Swept source OCT,Casia SS-1000; Tomey)
lOL tilt
Post-op 1 day ,1 week,1 month and 3 months lOL tilt(Swept source OCT,Casia SS-1000; Tomey)
lOL decentration
Post-op 1 day ,1 week,1 month and 3 months lOL decentration(Swept source OCT,Casia SS-1000; Tomey)
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)
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)
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)
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)
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)
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)
manifest refraction
Pre-op and post-op 1 day,1 week,1 month and 3 months manifest refraction
Monocular defocus curve
Post-op 1month,3 months monocular defocus curve
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)
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)

Full Information

First Posted
August 22, 2021
Last Updated
September 18, 2021
Sponsor
Wenzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05042856
Brief Title
To Evaluate IOL Position, Clinical Outcome of PanOptix in High Myopic Cataract Patients
Official Title
A Prospective, Single Center Study to Evaluate IOL Position, Clinical Outcome of PanOptix in High Myopic Cataract Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2021 (Anticipated)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wenzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, High Myopia
Keywords
PanOptix IOL, high myopic cataract patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PanOptix
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
PanOptix IOL implantation
Intervention Description
All the patients will be bilaterally implanted with PanOptix IOL，one eye will be randomized selected for monocular analysis of each patient.
Primary Outcome Measure Information:
Title
Effective Lens Position（ELP）
Description
Mean change of ELP for 3 months
Time Frame
3 months
Secondary Outcome Measure Information:
Title
capsule bending index（CBI）
Description
Post-op 1 day，1week，1month，and 3 months monocular CBI(Swept source OCT,Casia SS-1000; Tomey)
Time Frame
3months
Title
lOL tilt
Description
Post-op 1 day ,1 week,1 month and 3 months lOL tilt(Swept source OCT,Casia SS-1000; Tomey)
Time Frame
3 months
Title
lOL decentration
Description
Post-op 1 day ,1 week,1 month and 3 months lOL decentration(Swept source OCT,Casia SS-1000; Tomey)
Time Frame
3 months
Title
Monocular uncorrected distance visual acuity（UDVA）
Description
Pre-op and post-op 1 day,1 week,1 month and 3 months Monocular UDVA(Chinese standard logarithmic charts)
Time Frame
3 months
Title
Monocular best corrected distance visual acuity（BCDVA）(5m)
Description
Pre-op and post-op 1 day,1 week,1 month and 3 months Monocular BCDVA(5m)(Chinese standard logarithmic charts)
Time Frame
3 months
Title
Monocular uncorrected intermediate visual acuity（UIVA）
Description
Pre-op and post-op 1 day,1 week,1 month and 3 months Monocular UIVA(Chinese standard logarithmic charts)
Time Frame
3 months
Title
Monocular distance corrected intermediate visual acuity(DCIVA)(60cm)
Description
Pre-op and post-op 1 day,1 week,1 month and 3 months Monocular DCIVA(60cm)(Chinese standard logarithmic charts)
Time Frame
3 months
Title
Monocular uncorrected near visual acuity（UNVA）
Description
Pre-op and post-op 1 day,1 week,1 month and 3 months Monocular UNVA(Chinese standard logarithmic charts)
Time Frame
3 months
Title
Monocular distance corrected near visual acuity(DCNVA)(40cm)
Description
Pre-op and post-op 1 day,1 week,1 month and 3 months Monocular DCNVA(40cm)(Chinese standard logarithmic charts)
Time Frame
3 months
Title
manifest refraction
Description
Pre-op and post-op 1 day,1 week,1 month and 3 months manifest refraction
Time Frame
3 months
Title
Monocular defocus curve
Description
Post-op 1month,3 months monocular defocus curve
Time Frame
3 months
Title
modulation transfer function（MTF）
Description
Post-op 1 day,1 week,1 month and 3 months MTF(OPD-Scan III Analyzer,NIDEK CO.,LTD.,Tokyo,Japan)
Time Frame
3 months
Title
high-order aberrations（HOA）
Description
Post-op 1 day,1 week,1 month and 3 months HOA(OPD-Scan III Analyzer,NIDEK CO.,LTD.,Tokyo,Japan)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yinying zhao
Phone
+86 13957763247
Email
ginger146@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yune zhao, MD
Organizational Affiliation
Wenzhou Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Ophthalmology and Optometry Hospital
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325027
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhao yun-e
Phone
+86 13819707056

12. IPD Sharing Statement

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

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