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A randomized controlled clinical study on the efficacy and safety of CO2 Laser-Assisted Sclerectomy Surgery and traditional trabeculectomy in the treatment of primary open-angle glaucoma

A randomized controlled clinical study on the efficacy and safety of CO2 Laser-Assisted Sclerectomy Surgery and traditional trabeculectomy in the treatment of primary open-angle glaucoma

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027900
Enrollment
Unknown
Registered
2019-12-03
Start date
2020-01-01
Completion date
Unknown
Last updated
2020-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

glaucoma

Interventions

CLASS Group:CO2 Laser-Assisted Sclerectomy Surgery
Primary Open Angle Glaucoma Group:Primary Open Angle Glaucoma

Sponsors

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The patient is over 18 years old. 2. The target eye was diagnosed as primary open-angle glaucoma (POAG). Diagnostic criteria: IOP>21mmHg;Depressions in the optic disc of the affected eye: C/D progressive increase, absolute value >0.5, or C/D asymmetry in both eyes (=0.2);Visual field changes: characteristic glaucoma visual field defect consistent with fundus examination;Angle shaffer is level 3 or 4. 3. Under the maximum tolerated dose treatment (for possible economic bear ability, memory problems, difficulties or drug intolerance, patients caused by drug control intraocular pressure), the goal of the eye of intraocular pressure over 21 MMHG (preoperative two consecutive measurements were higher than 21 MMHG, but do not use the same day of continuous measurements) 4. No other eye diseases (except cataract) in the target eye. 5. Patients can be used for filtration surgery. 6. Non-target eye vision is better than 20/200. 7. The patients and their families volunteered to participate in the study and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. The target eye has undergone other internal eye procedures, including and not limited to filtration (penetration or nonconventional) anti-glaucoma surgery, laser atrial angleplasty, keratoplasty, and other internal eye laser procedures other than laser trabecular plasty. 2. Laser trabecular plasty was performed on the target eye within the last three months. 3. The target eye is amorphous eye. 4. Cataract surgery requiring scleral tunnel or conjunctival incision was performed on the target eye. 5. Either eye is proliferative or severe non-proliferative diabetic retinopathy. 6. After the dilated pupil of the target eye, the pupil diameter is less than 2 mm. 7. The target eye is congenital antebrum Angle dysplasia. 8. In addition to glaucoma, there are other eye diseases causing optic nerve damage. 9. The target eye has RVO (retinal vein occlusion) or RAO (retinal artery occlusion).

Design outcomes

Primary

MeasureTime frame
intraocular pressure;

Secondary

MeasureTime frame
Number of anti-glaucoma medications;Incidence of complications;Best corrected vision;

Countries

China

Contacts

Public ContactGuo Wenyi

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

wyguo@163.com+86 13816880563

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026