Clincosm LogoSign in Get a demo

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

Sponsor
Wenzhou Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05042856
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
12
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: PanOptix IOL implantation
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective, Single Center Study to Evaluate IOL Position, Clinical Outcome of PanOptix in High Myopic Cataract Patients
Anticipated Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Effective Lens Position（ELP） [3 months]

    Mean change of ELP for 3 months

Secondary Outcome Measures

  1. capsule bending index（CBI） [3months]

    Post-op 1 day，1week，1month，and 3 months monocular CBI(Swept source OCT,Casia SS-1000; Tomey)

  2. lOL tilt [3 months]

    Post-op 1 day ,1 week,1 month and 3 months lOL tilt(Swept source OCT,Casia SS-1000; Tomey)

  3. lOL decentration [3 months]

    Post-op 1 day ,1 week,1 month and 3 months lOL decentration(Swept source OCT,Casia SS-1000; Tomey)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. manifest refraction [3 months]

    Pre-op and post-op 1 day,1 week,1 month and 3 months manifest refraction

  11. Monocular defocus curve [3 months]

    Post-op 1month,3 months monocular defocus curve

  12. 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)

  13. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ophthalmology and Optometry Hospital Wenzhou Zhejiang China 325027

Sponsors and Collaborators

  • Wenzhou Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yune Zhao, Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical University
ClinicalTrials.gov Identifier:
NCT05042856
Other Study ID Numbers:
  • ZYY-PanOptix IOL
First Posted:
Sep 13, 2021
Last Update Posted:
Sep 21, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yune Zhao, Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical University
PanOptix IOL
high myopic cataract patients
Additional relevant MeSH terms:
Cataract

Study Results

No Results Posted as of Sep 21, 2021