Glaucoma, Angle-Closure
Conditions
Keywords
Ex-PRESS, glaucoma, filtration surgery, phacoemulsification
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.
Interventions
PROCEDUREEx-PRESS and phacoemulsification
Sponsors
Wenzhou Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, interventional and monocentric study based in a university hospital setting
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular pressure (IOP) | 36 months | In millimeters of mercury (mmHg), measured with the Goldmann applanation tonometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of intraocular pressure lowering medications | 2 weeks, 1 month, 3 months, 6 months, 12 months,18 months, 24 months, 30 months,36 months. | Number of drops and oral medications used by the patient compared to baseline |
| 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 lines reduction or improvement from baseline on Snellen acuity chart |
| Intraocular pressure (IOP) | 2 weeks, 1 month, 3 months, 6 months, 12 months,18 months, 24 months, 30 months,36 months. | In millimeters of mercury (mmHg), measured with the Goldmann applanation tonometer |
| Anterior chamber distance(ACD) | 3 months | The distance from inner corneal surface to lens measured by AS-OCT |
| Angle opening distance(AOD500) | 3 months | Angle opening distance 500um from the scleral spur measured by AS-OCT |
| Corneal endothelial cell density | 3 months | Use non-contact specular microscope to count the endothelial cell density (cells/mm2) |
Countries
China
Contacts
Primary ContactLi Nie, MD
Backup ContactAi wu Fang, MD
Outcome results
None listed