Comparing Monofocal IOLs in Highly Myopic Cataract Patients
Comparison of the Clinical Outcomes of Extended Depth of Focus Intraocular Lenses and Monofocal Intraocular Lenses in Patients With High Myopia Undergoing Cataract Surgery.
1 other identifier
observational
60
1 country
1
Brief Summary
Comparison of Postoperative Outcomes in Patients with High Myopia Undergoing Cataract Surgery Implanted with Extended Depth of Focus Intraocular Lens (ICB00) and Monofocal Intraocular Lens (ZCB00)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2025
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
March 12, 2025
CompletedStudy Start
First participant enrolled
April 1, 2025
CompletedFirst Posted
Study publicly available on registry
April 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 30, 2026
April 2, 2025
March 1, 2025
1.2 years
March 12, 2025
March 28, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Defocus curve
On the basis of BCDVA, add +2.5\~-5.0D spherical lenses (decreasing at intervals of 0.5D) before the patient's operation, record the logMAR vision of the patient at each added spherical lens degree, and draw the average Defocus Curve with the added spherical lens degree as the abscissa and the average vision of each corresponding degree as the ordinate.
Three months after operation
Far, middle and near vision
The naked eye vision was measured at 5m, 70cm and 40cm respectively.
Three months after operation
Study Arms (2)
ICB00 implantation after cataract surgery.
Undergoing micro-incision cataract surgery with the implantation of an extended depth of focus (EDOF) intraocular lens (ICB).
ZCB00 implantation after cataract surgery.
Performing micro-incision cataract surgery and implanting a ZCB (presumably an abbreviation specific to a certain type of intraocular lens) intraocular lens
Interventions
no intervention
Eligibility Criteria
Included in Eye Hospital of Wenzhou Medical University for "phacoemulsification combined with intraocular lens implantation"
You may qualify if:
- : The patients are between 40 and 70 years old.
- : Ocular axis \> 26mm
- : Able to understand, cooperate and complete all follow-up.
You may not qualify if:
- : Moderate and severe dry eye
- : There is macular degeneration complicated by high myopia.
- : Combined with other ophthalmic diseases
- : Previous history of ophthalmic surgery.
- : There are intraoperative or postoperative complications.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ophthalmology and Optometry Hos
Hanzhou, Zhejian, 310000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhao Yune
Ethics Committee of the affiliated Ophthalmology Hospital of Wenzhou Medical University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice president of Eye Hospital of Wenzhou Medical University
Study Record Dates
First Submitted
March 12, 2025
First Posted
April 2, 2025
Study Start
April 1, 2025
Primary Completion (Estimated)
May 30, 2026
Study Completion (Estimated)
May 30, 2026
Last Updated
April 2, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share