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

NCT ID: NCT04912362

Last Updated: 2021-06-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2023-08-31

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.

Conditions

Glaucoma, Open-angle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

YAG iridotomy+CLASS

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

Group Type: EXPERIMENTAL

YAG iridotomy

Intervention Type: DEVICE

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

CLASS

CO2 Laser-Assisted Sclerectomy Surgery only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

YAG iridotomy

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kaijun Wang, MD

Role: STUDY_DIRECTOR

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

Locations

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

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Kaijun Wang, MD

Role: CONTACT

wkj992@126.com

+86 0571 87783759

Facility Contacts

Kaijun Wang, MD

Role: primary

wkj992@126.com

+86 0571 87783759

Other Identifiers

2020-527

Identifier Type: -

Identifier Source: org_study_id