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

Glaucoma, Open-angle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04912362
• Other study ID #: 2020-527
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: August 2023

Study information

• Verified date: August 2020
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Kaijun Wang, MD
• Phone: +86 0571 87783759
• Email: wkj992[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle

Intervention

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

Locations

Country	Name	City	State
China	Eye center, 2nd Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure	Intraocular pressure	1 year
Primary	Peripheral anterior synechia	Incidence of peripheral anterior synechia	1 year