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

Wenzhou Medical University

Status: Unknown

Conditions: Glaucoma, Angle-Closure

Treatments: Procedure: Ex-PRESS and phacoemulsification

Study type: Interventional

Funder types: Other

Identifiers

NCT03323138

NL-HZ

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Ex-PRESS and phacoemulsification

Experimental group

Description:

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

Treatment:

Procedure: Ex-PRESS and phacoemulsification