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

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

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

Study Overview

• Status: Recruiting
• Conditions: Glaucoma, Open-Angle
• Intervention / Treatment: Procedure: phacoemulsification

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kaijun Wang, MD; Phone Number: +86 0571 87783759; Email: wkj992@126.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Eye Center, the 2nd Affiliated Hospital, Medical College of Zhejiang University
      • Contact: Kaijun Wang, MD; Phone Number: +86 0571 87783759; Email: wkj992@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CLASS+PHACO; CO2 Laser-Assisted Sclerectomy Surgery combined with phacoemulsification	Procedure: phacoemulsification; Group A: class combined with phacoemulsification
No Intervention: CLASS; CO2 Laser-Assisted Sclerectomy Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of peripheral anterior synechia	Incidence of peripheral anterior synechia	1 year
Intraocular pressure	Intraocular pressure	1 year

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Director: Kaijun Wang, MD, Eye Center, the 2nd Affiliated Hospital, Medical College of Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2020
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: June 1, 2021
• First Submitted That Met QC Criteria: June 4, 2021
• First Posted (Actual): June 9, 2021

Study Record Updates

• Last Update Posted (Actual): June 9, 2021
• Last Update Submitted That Met QC Criteria: June 4, 2021
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: 2020-528

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No