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

Zhejiang University logo

Zhejiang University

Status

Unknown

Conditions

Glaucoma, Open-Angle

Treatments

Procedure: phacoemulsification;

Study type

Interventional

Funder types

Other

Identifiers

NCT04920227
2020-528

Details and patient eligibility

About

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

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

50 to 80 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

CLASS+PHACO
Experimental group
Description:
CO2 Laser-Assisted Sclerectomy Surgery combined with phacoemulsification
Treatment:
Procedure: phacoemulsification;
CLASS
No Intervention group
Description:
CO2 Laser-Assisted Sclerectomy Surgery

Trial contacts and locations

1

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Central trial contact

Kaijun Wang, MD

Data sourced from clinicaltrials.gov

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