Study on Ex-PRESS Implantation Combined With Phacoemulsification in Primary Angle-closure Glaucoma

Not Applicable

• Conditions: Glaucoma, Angle-Closure
• Interventions: Procedure: Ex-PRESS and phacoemulsification

• Registration Number: NCT03323138
• Lead Sponsor: Wenzhou Medical University

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 Timeline

• Study Start: 2012-07-01
• Status Verified: 2017-10
• Study First Submitted: 2017-10-24
• Study First Submitted QC: 2017-10-25
• Last Update Submitted: 2017-10-25
• Study First Posted: 2017-10-26
• Last Update Posted: 2017-10-26
• Primary Completion: 2018-01
• Study Completion: 2018-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ex-PRESS and phacoemulsification	Ex-PRESS and phacoemulsification	A treatment session of PACG coexisting cataract treated with phacoemulsification combined with P50 Ex-PRESS miniature glaucoma device (Alcon Laboratories, Fort Worth, Texas, USA).

Primary Outcome Measures

Name	Time	Method
Intraocular pressure (IOP)	36 months	In millimeters of mercury (mmHg), measured with the Goldmann applanation tonometer

Secondary Outcome Measures

Name	Time	Method
Anterior chamber distance(ACD)	3 months	The distance from inner corneal surface to lens measured by AS-OCT
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
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
Angle opening distance(AOD500)	3 months	Angle opening distance 500um from the scleral spur measured by AS-OCT
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
Corneal endothelial cell density	3 months	Use non-contact specular microscope to count the endothelial cell density (cells/mm2)

Trial Locations

Locations (1)

Ophthalmology and Optometry Hospital , Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China