Comparation of CLASS Combined With Phacoemulsification and CLASS Alone in the Treatment of Primary Open Angle Glaucoma

NCT ID: NCT04920227

Last Updated: 2021-06-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-02
• Study Completion Date: 2023-08-31

Brief Summary

To compare the effect of intraocular pressure control and the incidence of peripheral anterior synechia between CLASS combined with phacoemulsification and CLASS alone in the treatment of primary open-angle glaucoma

Detailed Description

Group A: CO2 Laser-Assisted Sclerectomy Surgery combined with phacoemulsification; Group B: simple CO2 Laser-Assisted Sclerectomy Surgery. The patients were followed up for 1 year. The incidence of peripheral anterior synechia and Intraocular pressure changes at 1 day, 1 week, 1 month, 2 months, 3 months, 6 months and 12 months were observed and compared between the two groups.

Conditions

Glaucoma, Open-Angle

Study Design

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

Study Groups

CLASS+PHACO

CO2 Laser-Assisted Sclerectomy Surgery combined with phacoemulsification

Group Type: EXPERIMENTAL

phacoemulsification;

Intervention Type: PROCEDURE

Group A: class combined with phacoemulsification

CLASS

CO2 Laser-Assisted Sclerectomy Surgery

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

phacoemulsification;

Group A: class combined with phacoemulsification

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Primary open-angle glaucoma patients with cataract in our Ophthalmic Center;
• Topical use of hypotensive drugs in the treatment of poor or intolerable intraocular pressure control;
• The patients were aged from 50 to 80 years old, regardless of gender;
• Class operation and phacoemulsification were 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;
• Angle of the chamber was narrow by angle microscopy (Schaffer grade III and below);
• Patients diagnosed as secondary glaucoma;
• Optic atrophy caused by other reasons;
• The serious complications such as posterior capsule rupture and choroidal hemorrhage occurred during the operation;
• Serious complications of eyes occurred 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, and may confuse the research results.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 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

Eye Center, the 2nd Affiliated Hospital, Medical College of Zhejiang University

Locations

Eye Center, the 2nd Affiliated Hospital, Medical College of 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

2020-528

Identifier Type: -

Identifier Source: org_study_id