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.
91 studies on the registry are indexed under Glaucoma, Angle-Closure; 17 are open to participants now.
This study's planned enrollment of 40 is below the median of 57 across 58 interventional studies indexed under Glaucoma, Angle-Closure.
Browse Glaucoma, Angle-Closure studies →Wenzhou Medical University is the lead sponsor of 94 studies on the registry; 8 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Wenzhou Medical University