To Evaluate IOL Position, Clinical Outcome of PanOptix in High Myopic Cataract Patients
A Prospective, Single Center Study to Evaluate IOL Position, Clinical Outcome of PanOptix in High Myopic Cataract Patients
1 other identifier
interventional
20
1 country
1
Brief Summary
To evaluate IOL position, clinical outcome of PanOptix in high myopic cataract patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2021
CompletedFirst Posted
Study publicly available on registry
September 13, 2021
CompletedStudy Start
First participant enrolled
October 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedSeptember 21, 2021
September 1, 2021
12 months
August 22, 2021
September 18, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effective Lens Position（ELP）
Mean change of ELP for 3 months
3 months
Secondary Outcomes (13)
capsule bending index（CBI）
3months
lOL tilt
3 months
lOL decentration
3 months
Monocular uncorrected distance visual acuity（UDVA）
3 months
Monocular best corrected distance visual acuity（BCDVA）(5m)
3 months
- +8 more secondary outcomes
Study Arms (1)
PanOptix
EXPERIMENTALAll the patients will be bilaterally implanted with PanOptix IOL，one eye will be randomized selected for monocular analysis of each patient.
Interventions
All the patients will be bilaterally implanted with PanOptix IOL，one eye will be randomized selected for monocular analysis of each patient.
Eligibility Criteria
You may qualify if:
- Patients over 18 years old
- ≤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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ophthalmology and Optometry Hospital
Wenzhou, Zhejiang, 325027, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
yune zhao, MD
Wenzhou Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice president of Eye Hospital of Wenzhou Medical University
Study Record Dates
First Submitted
August 22, 2021
First Posted
September 13, 2021
Study Start
October 1, 2021
Primary Completion
September 30, 2022
Study Completion
September 30, 2022
Last Updated
September 21, 2021
Record last verified: 2021-09