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

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04912362
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 35
• Patients Per Site Per Month: 2.3

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Open-angle	Device: YAG iridotomy	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Effectiveness of YAG Laser Iridotomy in Preventing Peripheral Anterior Synechia After CO2 Laser-Assisted Sclerectomy Surgery in Primary Open Angle Glaucoma
• Actual Study Start Date: Sep 1, 2020
• Anticipated Primary Completion Date: Aug 1, 2023
• Anticipated Study Completion Date: Aug 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Intraocular pressure [1 year]

   Intraocular pressure

2. Peripheral anterior synechia [1 year]

   Incidence of peripheral anterior synechia

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eye center, 2nd Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang	China

Sponsors and Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
• ClinicalTrials.gov Identifier: NCT04912362
• Other Study ID Numbers: 2020-527
• First Posted: Jun 3, 2021
• Last Update Posted: Jun 3, 2021
• Last Verified: Aug 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle

Study Results

No Results Posted as of Jun 3, 2021