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

NCT04920227 | Unknown

• 1 other identifier: 2020-528
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Glaucoma, Open-Angle

Outcome Measures

Primary Outcomes (2)

• Incidence of peripheral anterior synechia

  Incidence of peripheral anterior synechia

  1 year

• Intraocular pressure

  Intraocular pressure

  1 year

Study Arms (2)

CLASS+PHACO

EXPERIMENTAL

CO2 Laser-Assisted Sclerectomy Surgery combined with phacoemulsification

Procedure: phacoemulsification;

CLASS

NO INTERVENTION

CO2 Laser-Assisted Sclerectomy Surgery

Interventions

phacoemulsification; PROCEDURE

Group A: class combined with phacoemulsification

CLASS+PHACO

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Cataract Extraction; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Officials

• Kaijun Wang, MD

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

  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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 9, 2021
• Study Start: September 2, 2020
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: June 9, 2021

Record last verified: 2020-08

Locations

CN (1)