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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04912362
Other study ID # 2020-527
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date August 2023

Study information

Verified date August 2020
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Kaijun Wang, MD
Phone +86 0571 87783759
Email wkj992@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To investigate the effectiveness of YAG laser iridotomy in preventing peripheral anterior synechia after CO2 Laser-Assisted Sclerectomy Surgery and the long-term effect of reducing intraocular pressure


Description:

Group A: YAG laser iridotomy was performed one week before operation, followed by CO2 Laser-Assisted Sclerectomy Surgery; Group B: only CO2 Laser-Assisted Sclerectomy Surgery; The patients were followed up for 1 year to observe and compare the difference of the incidence of peripheral anterior synechia and the effect of long-term intraocular pressure control between the two groups.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date August 2023
Est. primary completion date August 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Primary open angle glaucoma patients in Ophthalmic Center; - Topical use of hypotensive drugs in the treatment of poor or intolerable intraocular pressure control; - The patients were 18 to 50 years old, regardless of gender; - Class operation was performed; - 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: - Allergic to any perioperative medication in this study; - History of ocular trauma; - Any previous intraocular surgery; - Gonioscopy showed a narrow angle (Schaffer III or below); - Secondary glaucoma was diagnosed; - Optic atrophy caused by other reasons; - Severe complications such as rupture of posterior capsule and choroidal hemorrhage occurred during operation; - Patients with severe ocular complications after operation - 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 significant risk, may confuse the results of the study, or may significantly interfere with the patient's participation in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
YAG iridotomy
YAG iridotomy was performed one week before operation, and then CO2 Laser-Assisted Sclerectomy Surgery was performed

Locations

Country Name City State
China Eye center, 2nd Affiliated Hospital, School of Medicine, Zhejiang University Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intraocular pressure Intraocular pressure 1 year
Primary Peripheral anterior synechia Incidence of peripheral anterior synechia 1 year
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