Glaucoma, Open-Angle Clinical Trial
Official title:
Comparison of ExPress Implantation Versus Partial Deep Sclerectomy Combined With ExPress Implantation With Simultaneously Phacoemulsification
Verified date | January 2019 |
Source | Military Institute of Medicine, Poland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is to compare the effectiveness and safety profile of ExPress implantation versus partial deep sclerectomy combined with ExPress implantation with simultaneously phacoemulsification.
Status | Completed |
Enrollment | 186 |
Est. completion date | December 1, 2017 |
Est. primary completion date | December 1, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: - co-existing glaucoma and cataract (NC1, NC2) classified by means of the LOCS III scale - patients with primary open-angle glaucoma (POAG), pseudoexfoliative glaucoma (PGX) and normal tension glaucoma (NTG), in which a satisfactory IOP level was not achieved despite maximum tolerable hypotensive treatment, both topical and systemic, - documented progression of loss of field of vision, - significant daily IOP fluctuations, - no cooperation from patient with regard to application of anti-glaucoma treatment, - allergy to topical medication - written consent to involvement and participation in the study for a period of at least 24 months Exclusion Criteria: - no consent to participation in the study - prior surgical and laser procedures in the area of the eye - narrow- or closed-angle glaucoma - post-inflammatory or post-traumatic secondary glaucoma - chronic illness of the cornea or optic nerve - advanced macular degeneration - active inflammatory process - pregnancy - systemic steroid therapy |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Military Institute of Medicine, Poland |
Bissig A, Feusier M, Mermoud A, Roy S. Deep sclerectomy with the Ex-PRESS X-200 implant for the surgical treatment of glaucoma. Int Ophthalmol. 2010 Dec;30(6):661-8. doi: 10.1007/s10792-010-9382-z. Epub 2010 Jun 16. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | IOP | the change in level of intraocular pressure | baseline, and 24th month after surgery | |
Primary | CDVA | the change in corrected distance visual acuity | baseline, and 24th month after surgery | |
Primary | number of drugs | the change in number of antiglaucoma medications | baseline, and 24th month after surgery | |
Secondary | number of complications | rate of complications | in a day of surgery |
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