Combined Ex-PRESS Implantation Alone or With Phacoemulsification for Glaucoma Associated With Cataract

Glaucoma and Ocular Hypertension Clinical Trial

Official title:

To Check the Efficacy and Saftey of Combined Ex-PRESS Implantation Alone or With Phacoemulsification for Glaucoma Associated With Cataract

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02209961
• Other study ID #: 0054-13
• Status: Enrolling by invitation
• Phase: N/A
• First received: March 19, 2014
• Last updated: August 5, 2014
• Start date: March 2014
• Est. completion date: June 2016

Study information

• Verified date: August 2014
• Source: Hillel Yaffe Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

A prospective study reporting on Ex-PRESS shunt implantation alone or combined cataract and glaucoma surgery.

Description:

The occurrence of both glaucoma and clinically relevant cataract in the same individual is a frequent condition, especially in the elderly population. Besides age, this might be related to the possible role of antiglaucoma medications in the progression of lens opacity.When both procedures are required, these can be performed separately or in combination.

Glaucoma filtering surgery is indicated when glaucomatous damage progresses despite the lower level of intraocular pressure (IOP) obtained with pharmacological and/or laser treatment.

The Ex-PRESS is a miniature stainless steel glaucoma device, developed as an alternative to trabeculectomy and to the other types of glaucoma filtering surgery for patients with POAG. This procedure would be theoretically more reproducible and simple to perform as well as less traumatic to the ocular tissue than traditional filtering surgery. The implant is inserted at the limbus under a conjunctival flap and diverts the aqueous humour from the anterior chamber to the subconjunctival space, obtaining the formation of a conjunctival filtration bleb, in a similar way to trabeculectomy. This procedure can be performed on its own or in combination with phacoemulsification.

This study is aimed to test the efficacy and saftey of Ex-PRESS shunt implantation alone or combined cataract and glaucoma surgery in patients with medically uncontrolled glaucoma and cataract .

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: June 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• age above 18

Exclusion Criteria:

• congenital glaucoma

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma and Ocular Hypertension
• Ocular Hypertension

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure change in Ex-PRESS shunt implantation alone or combined cataract and glaucoma surgery in patients with medically uncontrolled glaucoma and cataract .	to check the change in intraocular pressure after EX-PRESS shunt implantation	within one to two years post surgery	No