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Clinical Trials/NCT05042856
NCT05042856
Unknown
Not Applicable

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

Wenzhou Medical University1 site in 1 country20 target enrollmentOctober 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cataract
Sponsor
Wenzhou Medical University
Enrollment
20
Locations
1
Primary Endpoint
Effective Lens Position(ELP)
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2021
End Date
September 30, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yune Zhao

Vice president of Eye Hospital of Wenzhou Medical University

Wenzhou Medical University

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.

Outcomes

Primary Outcomes

Effective Lens Position(ELP)

Time Frame: 3 months

Mean change of ELP for 3 months

Secondary Outcomes

  • Monocular distance corrected near visual acuity(DCNVA)(40cm)(3 months)
  • capsule bending index(CBI)(3months)
  • Monocular uncorrected distance visual acuity(UDVA)(3 months)
  • Monocular uncorrected intermediate visual acuity(UIVA)(3 months)
  • lOL tilt(3 months)
  • lOL decentration(3 months)
  • Monocular best corrected distance visual acuity(BCDVA)(5m)(3 months)
  • Monocular uncorrected near visual acuity(UNVA)(3 months)
  • modulation transfer function(MTF)(3 months)
  • Monocular distance corrected intermediate visual acuity(DCIVA)(60cm)(3 months)
  • manifest refraction(3 months)
  • high-order aberrations(HOA)(3 months)
  • Monocular defocus curve(3 months)

Study Sites (1)

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