Clinical trial NCT04920227: Comparation of CLASS Combined With Phacoemulsification and CLASS Alone in the Treatment of Primary Open Angle Glaucoma
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma, Open-Angle
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-09
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence of peripheral anterior synechia
timeFrame: 1 year
measure: Intraocular pressure
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Eye Center, the 2nd Affiliated Hospital, Medical College of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Eye Center, the 2nd Affiliated Hospital, Medical College of Zhejiang University
name: Kaijun Wang, MD
role: STUDY_DIRECTOR
References: