Cataract, High Myopia
Conditions
Keywords
PanOptix IOL, high myopic cataract patients
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.
Interventions
PROCEDUREPanOptix IOL implantation
All the patients will be bilaterally implanted with PanOptix IOL，one eye will be randomized selected for monocular analysis of each patient.
Sponsors
Wenzhou Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effective Lens Position（ELP） | 3 months | Mean change of ELP for 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| lOL tilt | 3 months | Post-op 1 day ,1 week,1 month and 3 months lOL tilt(Swept source OCT,Casia SS-1000; Tomey) |
| lOL decentration | 3 months | 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） | 3 months | 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) | 3 months | 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） | 3 months | 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) | 3 months | Pre-op and post-op 1 day,1 week,1 month and 3 months Monocular DCIVA(60cm)(Chinese standard logarithmic charts) |
| capsule bending index（CBI） | 3months | Post-op 1 day，1week，1month，and 3 months monocular CBI(Swept source OCT,Casia SS-1000; Tomey) |
| 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) |
| manifest refraction | 3 months | Pre-op and post-op 1 day,1 week,1 month and 3 months manifest refraction |
| Monocular defocus curve | 3 months | Post-op 1month,3 months monocular defocus curve |
| 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) |
| 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) |
| 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) |
Countries
China
Contacts
Primary Contactyinying zhao
Outcome results
None listed