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

Sponsor

Wenzhou Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03323138

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Angle-Closure	Procedure: Ex-PRESS and phacoemulsification	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Prospective, interventional and monocentric study based in a university hospital settingProspective, interventional and monocentric study based in a university hospital setting

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2012

Anticipated Primary Completion Date :

Jan 1, 2018

Anticipated Study Completion Date :

Dec 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Procedure: Ex-PRESS and phacoemulsification

Arm

Intervention/Treatment

Experimental: 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).

Procedure: Ex-PRESS and phacoemulsification

Outcome Measures

Primary Outcome Measures

Intraocular pressure (IOP) [36 months]
In millimeters of mercury (mmHg), measured with the Goldmann applanation tonometer

Secondary Outcome Measures

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
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
Corneal endothelial cell density [3 months]
Use non-contact specular microscope to count the endothelial cell density (cells/mm2)
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.