Back to resultsImproved Operation of Low Intraocular Pressure in Phacoemulsification for Patients With High Myopia Complicated With Cataract
Primary Purpose
High Myopia, Low Intraocular Pressure
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Supplement of perfusion fluid through the subiris suspensory ligament space from the lateral incision
Sponsored by
About this trial
This is an interventional treatment trial for High Myopia
Eligibility Criteria
Inclusion Criteria:
- The patients with high myopia and cataract who plan to receive cataract surgery in our hospital
- Surgery without complications
Exclusion Criteria:
- 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
Sites / Locations
- Eye Hospital of Wenzhou Medical CollegeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
High myopia with axial length between 26 mm and 28 mm
High myopia with axial length more than 28 mm
Arm Description
The patients' axial length is between 26 mm and 28 mm
The patients' axial length is more than 28 mm
Outcomes
Primary Outcome Measures
Intraocular pressure
Measurement of intraocular pressure during cataract surgery by iCare rebound tonometer
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05201677
Brief Title
Improved Operation of Low Intraocular Pressure in Phacoemulsification for Patients With High Myopia Complicated With Cataract
Official Title
Improved Operation of Low Intraocular Pressure in Phacoemulsification for Patients With High Myopia Complicated With Cataract
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yune Zhao
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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) .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Myopia, Low Intraocular Pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High myopia with axial length between 26 mm and 28 mm
Arm Type
Experimental
Arm Description
The patients' axial length is between 26 mm and 28 mm
Arm Title
High myopia with axial length more than 28 mm
Arm Type
Experimental
Arm Description
The patients' axial length is more than 28 mm
Intervention Type
Procedure
Intervention Name(s)
Supplement of perfusion fluid through the subiris suspensory ligament space from the lateral incision
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intraocular pressure
Description
Measurement of intraocular pressure during cataract surgery by iCare rebound tonometer
Time Frame
two minutes
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patients with high myopia and cataract who plan to receive cataract surgery in our hospital
Surgery without complications
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dandan Wang
Phone
18258227706
Email
wangdan4827716@yahoo.com.cn
Facility Information:
Facility Name
Eye Hospital of Wenzhou Medical College
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325027
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dandan Wang, MD
Phone
18258227706
Email
wangdan4827716@yahoo.com.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Improved Operation of Low Intraocular Pressure in Phacoemulsification for Patients With High Myopia Complicated With Cataract
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