- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05834465
High Intraocular Pressure After Cataract Surgery
June 27, 2023 updated by: Yune Zhao, Wenzhou Medical University
Efficacy Evaluation of Anterior Chamber Drainage in Patients for High Intraocular Pressure After Cataract Surgery
Effectiveness of anterior chamber drainage on the structure of the anterior chamber, the position of the intraocular lens and the shape of the corneal incision in the early stage of cataract surgery with high intraocular pressure
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
To explore the effect of different degrees of anterior chamber drainage on the structure of the anterior chamber, the position of the intraocular lens and the shape of the corneal incision in the early stage of cataract surgery with high intraocular pressure
Study Type
Observational
Enrollment (Estimated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Pingjun Chang
- Phone Number: 18868410303
- Email: 364669877@qq.com
Study Locations
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Zhejiang
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Wenzhou, Zhejiang, China
- Eye Hospital of Wenzhou Medical College
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Contact:
- Pingjun Chang
- Phone Number: 18868410303
- Email: 364669877@qq.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Included in Eye Hospital of Wenzhou Medical University for "phacoemulsification combined with intraocular lens implantation" 2 hours after using a non-contact tonometer (FT-1000, TOMEY, JAPAN) to check that the intraocular pressure exceeds 28mmHg accompanied by corneal edema, anterior chamber radiation and age-related cataract patients over 60 years of age is required.
Description
Inclusion Criteria:
- Patients over 60 years old who underwent simple age-related cataract surgery in Eye Hospital of Wenzhou Medical University, the operation was successful, and there were no intraoperative complications such as posterior capsule rupture;
- Measurements were taken before and after drainage, and all data were complete ;
- The patient agrees and accepts the study.
Exclusion Criteria:
- Preoperative glaucoma, ocular hypertension, iritis, uveitis and other eye diseases, as well as other eye diseases and serious systemic diseases that may affect the prognosis of surgery, such as corneal lesions, vitreous volume blood, retinal detachment, poor blood sugar control in diabetes, etc.
- Previous history of eye trauma, etc.
- Cannot cooperate with the completion of intraocular pressure measurement and CASIA2 examination.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Group 1
After using a non-contact tonometer to measure, the intraocular pressure is reduced by 0-10mmHg.
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Group 2
After using a non-contact tonometer to measure, the intraocular pressure is reduced by 10-20mmHg.
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Group 3
After using a non-contact tonometer to measure, the intraocular pressure is reduced over 20mmHg.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The position of IOL through tilt (tilt in degree)
Time Frame: Two hours after cataract surgery (i.e. before anterior chamber drainage)
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Evaluation of the position of IOL through tilt (tilt in degree)
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Two hours after cataract surgery (i.e. before anterior chamber drainage)
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|
The position of IOL through decentration (decentration in millimeter)
Time Frame: Two hours after cataract surgery (i.e. before anterior chamber drainage)
|
Evaluation of the position of IOL through decentration (decentration in millimeter)
|
Two hours after cataract surgery (i.e. before anterior chamber drainage)
|
|
The position of IOL through tilt (tilt in degree)
Time Frame: Immediately after anterior chamber drainage
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Evaluation of the position of IOL through tilt (tilt in degree)
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Immediately after anterior chamber drainage
|
|
The position of IOL through decentration (decentration in millimeter)
Time Frame: Immediately after anterior chamber drainage
|
Evaluation of the position of IOL through decentration (decentration in millimeter)
|
Immediately after anterior chamber drainage
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2023
Primary Completion (Estimated)
September 1, 2023
Study Completion (Estimated)
October 1, 2023
Study Registration Dates
First Submitted
March 24, 2023
First Submitted That Met QC Criteria
April 27, 2023
First Posted (Actual)
April 28, 2023
Study Record Updates
Last Update Posted (Actual)
June 29, 2023
Last Update Submitted That Met QC Criteria
June 27, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20230301CTR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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