Prospective Study on Ex-PRESS Implantation Combined With Phacoemulsification in Primary Angle-closure Glaucoma
Overview
- Phase
- Not Applicable
- Sponsor
- Wenzhou Medical University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Intraocular pressure (IOP)
Overview
Brief Summary
Primary angle-closure glaucoma (PACG) is common, phacotrabeculectomy is associated with a significant risk of complications.The Ex-PRESS shunt was introduced as a modification to trabeculectomy, with the theoretical advantages of reduced complications.Our purpose is to perform a prospective study to evaluate the clinical outcomes and safety of the Ex-PRESS shunt with cataract surgery for PACG patients coexisting cataract.
Detailed Description
The Ex-PRESS is a miniature stainless steel glaucoma device, developed as an alternative to trabeculectomy mainly for patients with primary open-angle glaucoma.It has been proved to be as effective as trabeculectomy in a series of researches. However the early postoperative complication of Ex-PRESS implantation is less frequent compared with trabeculectomy. Ex-PRESS was designed initially for open angle glaucoma, gradually some scholars used it in refractory postpenetrating keratoplasty glaucoma and in vitrectomized glaucoma,which showed that Ex-PRESS shunt implantation was an effective procedure too. We analyzed the clinical efficacy and safety of combined phacoemulsification and Ex-PRESS implantation for PACG patients with cataract. Data was recorded before surgery and postoperatively at 1 week and 1, 3, 6, 12,18,24,30,36 months，which included intraocular pressure (IOP), best corrected visual acuity (BCVA), number of medications, complications, corneal endothelial cell density and anterior segment optical coherence tomography(AS-OCT). Efficacy was assessed by IOP values and success rates. Complete success was determined by IOP between 5 and 21mmHg without medications.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The presence of PACG, angle peripheral anterior synechia (PAS) more than 180 degrees.
- •An indication for glaucoma filtering surgery based on uncontrolled IOP or progressive vision field defect despite antiglaucoma medications.
- •Mean vision field defect greater than 15dB.
- •The presence of a clinically significant decrease of visual acuity as a result of cataract, usually BCVA less than 0.6.
Exclusion Criteria
- •Patients unable to give informed consent.
- •Ocular infection or inflammation in the study eye in the 3 months prior to enrollment.
- •Intraocular surgery in the study eye in the 3 months prior to enrollment.
Outcomes
Primary Outcomes
Intraocular pressure (IOP)
Time Frame: 36 months
In millimeters of mercury (mmHg), measured with the Goldmann applanation tonometer
Secondary Outcomes
- Intraocular pressure (IOP)(2 weeks, 1 month, 3 months, 6 months, 12 months,18 months, 24 months, 30 months,36 months.)
- Best corrected visual acuity (BCVA)(2 weeks, 1 month, 3 months, 6 months, 12 months,18 months, 24 months, 30 months,36 months.)
- Number of intraocular pressure lowering medications(2 weeks, 1 month, 3 months, 6 months, 12 months,18 months, 24 months, 30 months,36 months.)
- Corneal endothelial cell density(3 months)
- Angle opening distance(AOD500)(3 months)
- Anterior chamber distance(ACD)(3 months)
Investigators
yin ying zhao
MD
Wenzhou Medical University