- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04912310
Efficacy Evaluation and Influencing Factors of Argon Laser Peripheral Iridoplasty in Acute Angle Closure Glaucoma
June 1, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
To investigate the changes of angle structure and intraocular pressure after argon laser peripheral iridoplasty in patients with acute angle closure glaucoma patients whose intraocular pressure could not be controlled by drug therapy during the major attack period.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
To evaluate intraocular pressure and anterior segment optical coherence tomography measurement parameters at baseline and each follow-up.
Each patient was followed up for 6 weeks for 9 times.
Visit 1st was baseline examination, visit 2nd was 1 hour after argon laser peripheral iridoplasty treatment, visit 3rd was 2 hours after argon laser peripheral iridoplasty treatment, visit 4th was 1 week after argon laser peripheral iridoplasty treatment, visit 5th was 2 week after argon laser peripheral iridoplasty treatment, and visit 6th was 1 month after argon laser peripheral iridoplasty treatment, visit 7th was 6 week after argon laser peripheral iridoplasty treatment.
Study Type
Interventional
Enrollment (Anticipated)
65
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China
- Recruiting
- Eye center, 2nd Affiliated Hospital, School of Medicine, Zhejiang University,
-
Contact:
- Kaijun Wang, MD
- Phone Number: +86 0571 87783759
- Email: wkj992@126.com
-
Sub-Investigator:
- Kaijun Wang, MD
-
-
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
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- One eye had an acute attack, which could not be relieved by medication, and the intraocular pressure was more than 21mmhg;
- The patients were 40 to 80 years old, regardless of gender;
- Patients are able and willing to comply with the research guidance and may complete all visits required by the research;
- Informed consent has been signed.
Exclusion Criteria:
- History of ocular trauma;
- Any previous intraocular surgery;
- Secondary glaucoma was diagnosed, including uveitis, neovascular glaucoma, glaucoma with elevated superior scleral venous pressure, lens dissolution glaucoma, glaucoma caused by lens dislocation, lens cortical glaucoma, pigmented glaucoma, etc;
- The patient's history indicated that he had severe dysfunction of heart, lung, liver and kidney;
- Women in pregnancy, lactation or planned pregnancy;
- The researchers believe that the patient's condition may put the patient at a significant risk, may confuse the results of the study, or may significantly interfere with the patient's participation in the study.
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
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Acute angle closure glaucoma
Argon laser peripheral iridoplasty
|
Argon laser peripheral iridoplasty was performed in patients with severe acute angle closure glaucoma whose intraocular pressure could not be controlled by medication
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intraocular pressure
Time Frame: 6 weeks
|
Intraocular pressure
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Kaijun Wang, MD, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
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 (Actual)
July 13, 2020
Primary Completion (Anticipated)
July 1, 2021
Study Completion (Anticipated)
July 1, 2021
Study Registration Dates
First Submitted
May 31, 2021
First Submitted That Met QC Criteria
June 1, 2021
First Posted (Actual)
June 3, 2021
Study Record Updates
Last Update Posted (Actual)
June 3, 2021
Last Update Submitted That Met QC Criteria
June 1, 2021
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-480
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.