Improved Operation of Low Intraocular Pressure in Phacoemulsification for Patients With High Myopia Complicated With Cataract
1 other identifier
interventional
60
1 country
1
Brief Summary
Approximately 60 participants at Eye Hospital of Wenzhou Medical University during October,2021 to January 2022 will be enroll in the investigators' study. And dived them randomly into 2 groups:High myopia with axial length between 26 mm and 28 mm and High myopia with axial length more than 28 mm (30 eyes) .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2021
Shorter than P25 for not_applicable
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
Study Start
First participant enrolled
November 1, 2021
CompletedFirst Submitted
Initial submission to the registry
November 23, 2021
CompletedFirst Posted
Study publicly available on registry
January 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedJanuary 21, 2022
January 1, 2022
4 months
November 23, 2021
January 20, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Intraocular pressure
Measurement of intraocular pressure during cataract surgery by iCare rebound tonometer
two minutes
Study Arms (2)
High myopia with axial length between 26 mm and 28 mm
EXPERIMENTALThe patients' axial length is between 26 mm and 28 mm
High myopia with axial length more than 28 mm
EXPERIMENTALThe patients' axial length is more than 28 mm
Interventions
After the capsule is filled with viscoelastic material, if the IOP is less than 10 mmHg, the investigators will supply the perfusion fluid through the subiris suspensory ligament space from the lateral incision.
Eligibility Criteria
You may qualify if:
- The patients with high myopia and cataract who plan to receive cataract surgery in our hospital
- Surgery without complications
You may not qualify if:
- Patients who had other ocular diseases or had undergone internal eye surgery
- Patients with a history of myopic laser surgery
- Previous history of eye trauma
- Previous use of medications/eye drops that may alter IOP
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yune Zhaolead
Study Sites (1)
Eye Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325027, China
Related Publications (1)
Wang D, Shi J, Guan W, Zhu M, Lou X, Zhao Y, Chang P, Zhao Y. Fluid Supplementation Through Weakened Zonules via Side-Port Incision to Maintain Intraocular Pressure in High Myopic Eyes. Ophthalmol Ther. 2023 Dec;12(6):3323-3336. doi: 10.1007/s40123-023-00814-w. Epub 2023 Oct 9.
PMID: 37812307DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Vice president of Eye Hospital of Wenzhou Medical University
Study Record Dates
First Submitted
November 23, 2021
First Posted
January 21, 2022
Study Start
November 1, 2021
Primary Completion
March 1, 2022
Study Completion
June 1, 2022
Last Updated
January 21, 2022
Record last verified: 2022-01