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

Not Applicable

• Conditions: Glaucoma, Open-Angle
• Interventions: Procedure: phacoemulsification;

• Registration Number: NCT04920227
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Status Verified: 2020-08
• Study Start: 2020-09-02
• Study First Submitted: 2021-06-01
• Study First Submitted QC: 2021-06-04
• Last Update Submitted: 2021-06-04
• Study First Posted: 2021-06-09
• Last Update Posted: 2021-06-09
• Primary Completion: 2023-08
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CLASS+PHACO	phacoemulsification;	CO2 Laser-Assisted Sclerectomy Surgery combined with phacoemulsification

Primary Outcome Measures

Name	Time	Method
Incidence of peripheral anterior synechia	1 year	Incidence of peripheral anterior synechia
Intraocular pressure	1 year	Intraocular pressure

Trial Locations

Locations (1)

Eye Center, the 2nd Affiliated Hospital, Medical College of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China