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Efficacy Evaluation and Influencing Factors of Argon Laser Peripheral Iridoplasty in Acute Angle Closure Glaucoma

Primary Purpose

Acute Angle-Closure Glaucoma

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Argon laser peripheral iridoplasty

About this trial

This is an interventional treatment trial for Acute Angle-Closure Glaucoma focused on measuring Acute angle-closure glaucoma, Argon laser peripheral iridoplasty

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Eye center, 2nd Affiliated Hospital, School of Medicine, Zhejiang University,Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acute angle closure glaucoma

Arm Description

Argon laser peripheral iridoplasty

Outcomes

Primary Outcome Measures

Intraocular pressure

Secondary Outcome Measures

Full Information

NCT ID

NCT04912310

First Posted

May 31, 2021

Last Updated

June 1, 2021

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT04912310

Brief Title

Efficacy Evaluation and Influencing Factors of Argon Laser Peripheral Iridoplasty in Acute Angle Closure Glaucoma

Official Title

Efficacy Evaluation and Influencing Factors of Argon Laser Peripheral Iridoplasty in Acute Angle Closure Glaucoma

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Unknown status

Study Start Date

July 13, 2020 (Actual)

Primary Completion Date

July 2021 (Anticipated)

Study Completion Date

July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Angle-Closure Glaucoma

Keywords

Acute angle-closure glaucoma, Argon laser peripheral iridoplasty

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Acute angle closure glaucoma

Arm Type

Experimental

Arm Description

Argon laser peripheral iridoplasty

Intervention Type

Device

Intervention Name(s)

Argon laser peripheral iridoplasty

Intervention Description

Argon laser peripheral iridoplasty was performed in patients with severe acute angle closure glaucoma whose intraocular pressure could not be controlled by medication

Primary Outcome Measure Information:

Title

Intraocular pressure

Description

Intraocular pressure

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

kaijun wang, MD

Phone

+86 0571 87783759

wkj992@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

kaijun wang, MD

Organizational Affiliation

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Official's Role

Study Director

Facility Information:

Facility Name

Eye center, 2nd Affiliated Hospital, School of Medicine, Zhejiang University,

City

Hangzhou

State/Province

Zhejiang

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kaijun Wang, MD

Phone

+86 0571 87783759

wkj992@126.com

First Name & Middle Initial & Last Name & Degree

Kaijun Wang, MD

12. IPD Sharing Statement

Learn more about this trial

Efficacy Evaluation and Influencing Factors of Argon Laser Peripheral Iridoplasty in Acute Angle Closure Glaucoma

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