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

NCT04912362 | Unknown

• 1 other identifier: 2020-527
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Glaucoma, Open-angle

Outcome Measures

Primary Outcomes (2)

• Intraocular pressure

  Intraocular pressure

  1 year

• Peripheral anterior synechia

  Incidence of peripheral anterior synechia

  1 year

Study Arms (2)

YAG iridotomy+CLASS

EXPERIMENTAL

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

Device: YAG iridotomy

CLASS

NO INTERVENTION

CO2 Laser-Assisted Sclerectomy Surgery only

Interventions

YAG iridotomy DEVICE

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

YAG iridotomy+CLASS

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

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

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Kaijun Wang, MD

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

  STUDY DIRECTOR

Central Study Contacts

Kaijun Wang, MD

CONTACT

+86 0571 87783759; wkj992@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 3, 2021
• Study Start: September 1, 2020
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: June 3, 2021

Record last verified: 2020-08

Locations

CN (1)