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The Effectiveness of YAG Iridotomy in Preventing Peripheral Anterior Synechia After CLASS in Primary Open Angle Glaucoma

Primary Purpose

Glaucoma, Open-angle

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
YAG iridotomy
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Glaucoma, Open-angle

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Eye center, 2nd Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

YAG iridotomy+CLASS

CLASS

Arm Description

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

CO2 Laser-Assisted Sclerectomy Surgery only

Outcomes

Primary Outcome Measures

Intraocular pressure
Intraocular pressure
Peripheral anterior synechia
Incidence of peripheral anterior synechia

Secondary Outcome Measures

Full Information

First Posted
May 31, 2021
Last Updated
June 1, 2021
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT04912362
Brief Title
The Effectiveness of YAG Iridotomy in Preventing Peripheral Anterior Synechia After CLASS in Primary Open Angle Glaucoma
Official Title
Effectiveness of YAG Laser Iridotomy in Preventing Peripheral Anterior Synechia After CO2 Laser-Assisted Sclerectomy Surgery in Primary Open Angle Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (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
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-angle

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
YAG iridotomy+CLASS
Arm Type
Experimental
Arm Description
YAG iridotomy was performed one week before operation, and then CO2 Laser-Assisted Sclerectomy Surgery was performed
Arm Title
CLASS
Arm Type
No Intervention
Arm Description
CO2 Laser-Assisted Sclerectomy Surgery only
Intervention Type
Device
Intervention Name(s)
YAG iridotomy
Intervention Description
YAG iridotomy was performed one week before operation, and then CO2 Laser-Assisted Sclerectomy Surgery was performed
Primary Outcome Measure Information:
Title
Intraocular pressure
Description
Intraocular pressure
Time Frame
1 year
Title
Peripheral anterior synechia
Description
Incidence of peripheral anterior synechia
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kaijun Wang, MD
Phone
+86 0571 87783759
Email
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
Email
wkj992@126.com

12. IPD Sharing Statement

Learn more about this trial

The Effectiveness of YAG Iridotomy in Preventing Peripheral Anterior Synechia After CLASS in Primary Open Angle Glaucoma

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