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

Effectiveness of YAG Laser Iridotomy in Preventing Peripheral Anterior Synechia After CO2 Laser-Assisted Sclerectomy Surgery in Primary Open Angle Glaucoma

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

Study Overview

• Status: Recruiting
• Conditions: Glaucoma, Open-angle
• Intervention / Treatment: Device: YAG iridotomy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kaijun Wang, MD; Phone Number: +86 0571 87783759; Email: wkj992@126.com

Study Locations

• China
  • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: YAG iridotomy+CLASS; YAG iridotomy was performed one week before operation, and then CO2 Laser-Assisted Sclerectomy Surgery was performed	Device: YAG iridotomy; YAG iridotomy was performed one week before operation, and then CO2 Laser-Assisted Sclerectomy Surgery was performed
No Intervention: CLASS; CO2 Laser-Assisted Sclerectomy Surgery only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular pressure	Intraocular pressure	1 year
Peripheral anterior synechia	Incidence of peripheral anterior synechia	1 year

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Director: Kaijun Wang, MD, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): August 1, 2023

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: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: 2020-527

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No