Efficacy and safety of ExPress glaucoma filtration surgery in normal tension glaucoma
- Conditions
- ormal tension glaucoma
- Registration Number
- JPRN-UMIN000013243
- Lead Sponsor
- Alcon Japan
- Brief Summary
The mean IOP decreased from 14.8+/-2.3 mmHg at baseline to 10.0+/-3.1 mmHg at 12 months after surgery (P<0.0001). IOP reductions>20% were achieved by 61.5% of the eyes at 12 months. Adverse events were typical for filtration procedures, and none was deemed device-related. The mean corneal endothelial cell density had decreased by 3.3% at 12 months after surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 32
Not provided
1. pregnant and nursing women, and woman desiring future fertility during the study period 2. angle closure and secondary glaucoma 3. subject with a history of glaucoma surgery 4. subject to receive or has received penetrating keratoprasty 5. subject to have a problem for the IOP measurement with GAT 6. diagnosed as corneal dystrophy 7. subject with a history of any ocular surgery within 6 months 8. subject with infectious or non-infectious conjunctivitis, keratitis, or uveitis in one or both eyes 9. diagnosed as severe blepharitis or dry eye 10. subject with a metal allergy 11. judged as inappropriate for study subject 12. subject attended to the other clinical trial or study within 30 days before baseline visit
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method IOP lowering effect evaluating IOP reduction at 3,6 and 12 months after the surgery compared to the baseline. The number of cases who have over 20% IOP reduction at 3, 6 and 12 months postoperatively.
- Secondary Outcome Measures
Name Time Method