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

Primary Purpose

Glaucoma, Open-Angle

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
phacoemulsification;
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Open-Angle

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CLASS+PHACO

CLASS

Arm Description

CO2 Laser-Assisted Sclerectomy Surgery combined with phacoemulsification

CO2 Laser-Assisted Sclerectomy Surgery

Outcomes

Primary Outcome Measures

Incidence of peripheral anterior synechia
Incidence of peripheral anterior synechia
Intraocular pressure
Intraocular pressure

Secondary Outcome Measures

Full Information

First Posted
June 1, 2021
Last Updated
June 4, 2021
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT04920227
Brief Title
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2, 2020 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CLASS+PHACO
Arm Type
Experimental
Arm Description
CO2 Laser-Assisted Sclerectomy Surgery combined with phacoemulsification
Arm Title
CLASS
Arm Type
No Intervention
Arm Description
CO2 Laser-Assisted Sclerectomy Surgery
Intervention Type
Procedure
Intervention Name(s)
phacoemulsification;
Intervention Description
Group A: class combined with phacoemulsification
Primary Outcome Measure Information:
Title
Incidence of peripheral anterior synechia
Description
Incidence of peripheral anterior synechia
Time Frame
1 year
Title
Intraocular pressure
Description
Intraocular pressure
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kaijun Wang, MD
Phone
+86 0571 87783759
Email
wkj992@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaijun Wang, MD
Organizational Affiliation
Eye Center, the 2nd Affiliated Hospital, Medical College of Zhejiang University
Official's Role
Study Director
Facility Information:
Facility Name
Eye Center, the 2nd Affiliated Hospital, Medical College of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaijun Wang, MD
Phone
+86 0571 87783759
Email
wkj992@126.com

12. IPD Sharing Statement

Learn more about this trial

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

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