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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04920227
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
34.9
Anticipated Duration (Months)
2.3
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: phacoemulsification;
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 2, 2020
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Incidence of peripheral anterior synechia [1 year]

    Incidence of peripheral anterior synechia

  2. Intraocular pressure [1 year]

    Intraocular pressure

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Eye Center, the 2nd Affiliated Hospital, Medical College of Zhejiang University Hangzhou Zhejiang China

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT04920227
Other Study ID Numbers:
  • 2020-528
First Posted:
Jun 9, 2021
Last Update Posted:
Jun 9, 2021
Last Verified:
Aug 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle

Study Results

No Results Posted as of Jun 9, 2021