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

Glaucoma, Open-Angle Clinical Trial

Official title:

Comparation of CO2 Laser-Assisted Sclerectomy Surgery Combined With Phacoemulsification and CO2 Laser-Assisted Sclerectomy Surgery Alone in the Treatment of Primary Open Angle Glaucoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04920227
• Other study ID #: 2020-528
• Status: Recruiting
• Phase: N/A
• Start date: September 2, 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 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

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.

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: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle

Intervention

Procedure:
• phacoemulsification;
Group A: class combined with phacoemulsification

Locations

Country	Name	City	State
China	Eye Center, the 2nd Affiliated Hospital, Medical College of 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	Incidence of peripheral anterior synechia	Incidence of peripheral anterior synechia	1 year
Primary	Intraocular pressure	Intraocular pressure	1 year