An interventional study of Ex-PRESS and phacoemulsification in Glaucoma, Angle-Closure, sponsored by Wenzhou Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-26.
Sponsored by Wenzhou Medical University · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
A treatment session of PACG coexisting cataract treated with phacoemulsification combined with P50 Ex-PRESS miniature glaucoma device (Alcon Laboratories, Fort Worth, Texas, USA).
Procedure: Ex-PRESS and phacoemulsification
Intraocular pressure (IOP)
In millimeters of mercury (mmHg), measured with the Goldmann applanation tonometer
Time frame: 36 months
Intraocular pressure (IOP)
In millimeters of mercury (mmHg), measured with the Goldmann applanation tonometer
Time frame: 2 weeks, 1 month, 3 months, 6 months, 12 months,18 months, 24 months, 30 months,36 months.
Number of intraocular pressure lowering medications
Number of drops and oral medications used by the patient compared to baseline
Time frame: 2 weeks, 1 month, 3 months, 6 months, 12 months,18 months, 24 months, 30 months,36 months.
Best corrected visual acuity (BCVA)
Number of lines reduction or improvement from baseline on Snellen acuity chart
Time frame: 2 weeks, 1 month, 3 months, 6 months, 12 months,18 months, 24 months, 30 months,36 months.
Corneal endothelial cell density
Use non-contact specular microscope to count the endothelial cell density (cells/mm2)
Time frame: 3 months
Anterior chamber distance(ACD)
The distance from inner corneal surface to lens measured by AS-OCT
Time frame: 3 months
Angle opening distance(AOD500)
Angle opening distance 500um from the scleral spur measured by AS-OCT
Time frame: 3 months
Plan to share: Undecided
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Wenzhou Medical University