A Prospective, Single Center Study to Evaluate IOL Position, Clinical Outcome of PanOptix in High Myopic Cataract Patients
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Wenzhou Medical University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Effective Lens Position（ELP）
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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.
Arms & Interventions
PanOptix
All the patients will be bilaterally implanted with PanOptix IOL，one eye will be randomized selected for monocular analysis of each patient.
Intervention: PanOptix IOL implantation (Procedure)
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)
Investigators
Yune Zhao
Vice president of Eye Hospital of Wenzhou Medical University
Wenzhou Medical University