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

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

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

Study Overview

• Status: Unknown
• Conditions: Glaucoma and Ocular Hypertension

Detailed 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 .

• Study Type: Observational
• Enrollment (Anticipated): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patient with uncontrolled glaucoma

Description

Inclusion Criteria:

- age above 18

Exclusion Criteria:

- congenital glaucoma

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
glaucoma and ocular hypertension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hillel Yaffe Medical Center
• Investigators: Principal Investigator: Rana N Hanna, M.D, Hillel Yaffe Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: March 19, 2014
• First Submitted That Met QC Criteria: August 5, 2014
• First Posted (Estimate): August 6, 2014

Study Record Updates

• Last Update Posted (Estimate): August 6, 2014
• Last Update Submitted That Met QC Criteria: August 5, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Glaucoma; Ocular Hypertension; Cataract
• Other Study ID Numbers: 0054-13