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

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ClinicalTrials.gov Identifier: NCT02209961
Recruitment Status : Unknown
Verified August 2014 by Hillel Yaffe Medical Center.
Recruitment status was:  Enrolling by invitation
First Posted : August 6, 2014
Last Update Posted : August 6, 2014
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

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

Condition or disease
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 .


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: To Check the Efficacy and Saftey of Combined Ex-PRESS Implantation Alone or With Phacoemulsification for Glaucoma Associated With Cataract
Study Start Date : March 2014
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Glaucoma

Group/Cohort
glaucoma and ocular hypertension
glaucoma and ocular hypertension



Primary Outcome Measures :
  1. Intraocular pressure change in Ex-PRESS shunt implantation alone or combined cataract and glaucoma surgery in patients with medically uncontrolled glaucoma and cataract . [ Time Frame: within one to two years post surgery ]
    to check the change in intraocular pressure after EX-PRESS shunt implantation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patient with uncontrolled glaucoma
Criteria

Inclusion Criteria:

- age above 18

Exclusion Criteria:

- congenital glaucoma


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02209961


Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
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Principal Investigator: Rana N Hanna, M.D Hillel Yaffe Medical Center

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Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT02209961     History of Changes
Other Study ID Numbers: 0054-13
First Posted: August 6, 2014    Key Record Dates
Last Update Posted: August 6, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
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Glaucoma
Cataract
Ocular Hypertension
Eye Diseases
Lens Diseases