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

H

Hillel Yaffe Medical Center

Status

Unknown

Conditions

Glaucoma and Ocular Hypertension

Study type

Observational

Funder types

Other

Identifiers

NCT02209961
0054-13

Details and patient eligibility

About

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

Full 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 .

Enrollment

100 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • age above 18

Exclusion criteria

  • congenital glaucoma

Trial design

100 participants in 1 patient group

glaucoma and ocular hypertension
Description:
glaucoma and ocular hypertension

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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