glaucoma
Conditions
Interventions
Group 1:CLASS combined with phacoemulsification
Group 2:trabeculectomy combined with phacoemulsification
Group 3:phacoemulsification
Sponsors
Daping Hospital of Army Medical University, PLA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient aged 18 year or older. Patient must have primary open angle glaucoma in the study eye; diagnosis is based on glaucomatous optic neuropathy, Scheie angle of W and visual field defect attributed to glaucoma [at least 2 consecutive abnormal visual field test results, defined as a pattern SD (PSD) outside the 95% normal confidence limits and/or glaucoma Hemifield Test (Carl Zeiss Meditec Inc.]. The intraocular pressure can be controlled within 21mmHg with more than two kind of anti-glaucoma drugs. This IOP level of below or equal 21 mm Hg must be verified and recorded in the most recent 2 consecutive measurements (but not taken on the same day) before operation. 4>The cataract of the treated eye has obviously affected the daily life of the patients(the visual acuity 3 mo ago.Patients are reluctant to continue to use medication due to cost issues, memory problems, difficulty of instillation, ocular surface toxicity.Best corrected visual acuity (BCVA) better than 20/200 in the fellow eye.Optic neuropathy is attributed exclusively to glaucoma.
Exclusion criteria
Exclusion criteria: Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits. Diagnosis of glaucoma other than primary open angle glaucoma. History of previous intraocular surgery in the study eye; referring to but not limited to glaucoma filtering surgery (penetrating and nonpenetrating), laser gonioplasty, corneal transplant, and history of any other laser ocular procedures except for laser trabeculoplasty surgery.Laser trabeculoplasty surgery within the last 3 mo in the study eye. Visual acuity of study eye > 0.5. Study eye with no light perception vision. Patients with previous cataract surgery in the study eye.Proliferative or severe nonproliferative retinopathy in either eye.Eyes with (dilated) pupil diameter of <2 mm in the study eye. Discernable congenital anomaly of the anterior chamber angle in the study eye.Patients with neuropathy other than glaucoma in the study eye. Patient with RVO (retinal vein occlusion) or RAO (retinal artery occlusion) in the study eye. History of prior vitrectomy or vitreous hemorrhage (VH) in the study eye. Patient with media opacification that may interfere with optic nerve evaluation in the study eye. Patient with a history of severe eye trauma in the study eye. Patient with ocular malformations such as microphthalmia in the study eye.Patient with concurrent inflammatory/infective eye disorder (eg, episcleritis, scleritis) in the study eye. Study eye with active iris neovascularization. Patient with any sign of past or present uveitis (anterior/posterior); Patient with known allergy to the study medications. Patient with severe systemic disease or disabling conditions such as chronic renal failure requiring dialysis, severe and disenabling neurological disease, and postorgan transplants.Need for glaucoma surgery combined with other ocular procedures (that is, cataract surgery, penetrating keratoplasty, or retinal surgery) or anticipated need for additional ocular surgery.Patient participating in another clinical trial or participation in another clinical trial is <3 mo. Patient is pregnant or breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| intraocular pressure; | — |
Countries
China
Contacts
Public ContactYe Jian
Daping Hospital of Army Medical University, PLA.
Outcome results
None listed