Glaucoma
Conditions
Interventions
VISITS AND PROCEDURES:
The pre-operative visit will include an assessment of subject qualifications
for inclusion in the study according to the protocol inclusion/exclusion
criteria. Informed conse
Sponsors
Medpole SA
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subject Inclusion Criteria;One eye of the subject may be enrolled and treated in this clinical study.;Enrollment in this study is limited to subjects who meet the following inclusion criteria in the operative eye(s):;1) Male or female, of any race, and at least 43 years old at the time of the pre-operative examination and signing the consent form. 2) BSCVA of 20/25or better. 3) Have emmetropia (defined as a spherical equivalent of +/- 0.50 diopters with no more than 1.00 diopters of astigmatism. 4) Intra-ocular pressure greater than 24 mm of Hg adjusted for central corneal thickness. 5) Willing and medically safe to have a wash out of current ocular medications for two weeks (four weeks for topical prostaglandins). 6) Willing and capable of returning for follow-up examinations for the duration of the study (12 months). 7) MRSE between 3 month visits changes less than 0.50 D
Exclusion criteria
Exclusion criteria: Subject Exclusion Criteria;Subjects are not eligible for enrollment if they meet any of the following exclusion criteria:;1) Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study, as determined by verbal inquiry. 2) No more than two glaucoma pressure lowering ophthalmic drugs. 3) Concurrent use of topical or systemic medications that may impair healing. 4) History of any of the following medical conditions, or any other condition that could affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including, but not limited to unstable thyroid disorders and diabetes), lupus, and rheumatoid arthritis. 5) History of prior intraocular or corneal surgery (including cataract extraction), active ophthalmic disease (other than glaucoma) or, retinal detachment/repair, clinically significant lens opacity or clinical evidence of ocular trauma 6) Evidence of keratoconus, corneal dystrophy or irregularity, or abnormal videokeratography. 7) Known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course. 8) Participation in any other clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be a reduction of IOP. | — |
Secondary
| Measure | Time frame |
|---|---|
| Other key evaluation criteria include uncorrected and best corrected distance visual acuity, uncorrected and best-distance corrected near visual acuity, accommodative amplitude, manifest refraction, complication rates, and adverse event rates.. | — |
Countries
Netherlands
Outcome results
None listed