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| ID | Type | Description | Link |
|---|---|---|---|
| Second Line Trial | Other Identifier | Glaukos |
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Prospective, unmasked, randomized evaluation of the iStent in patients with primary open-angle glaucoma. Patients will be randomized to one of two groups: 1) iStent, or 2) medication.
Two hundred patients will be enrolled in the study at up to 21 clinical sites; follow-up is through 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stent | Active Comparator | One hundred patients will be randomized to implantation of two G2 stents in at least one eye. |
|
| Medication | Active Comparator | One hundred patients will be randomized to receive a fixed combination ocular hypotensive medication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iStent | Device | iStent |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean intraocular pressure (IOP) | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Wells, PharmD, MBA | Glaukos Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SV Malayan Ophthalmological Center | Yerevan | Armenia | ||||
| Allgemeines Krankenhaus Wien |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24855336 | Result | Fea AM, Belda JI, Rekas M, Junemann A, Chang L, Pablo L, Voskanyan L, Katz LJ. Prospective unmasked randomized evaluation of the iStent inject ((R)) versus two ocular hypotensive agents in patients with primary open-angle glaucoma. Clin Ophthalmol. 2014 May 7;8:875-82. doi: 10.2147/OPTH.S59932. eCollection 2014. |
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| latanoprost/timolol | Drug | Combination latanoprost/timolol |
|
| Vienna |
| 1090 |
| Austria |
| CHU de Lyon Hopital Edouard Herriot | Lyon | 69437 | France |
| CHNO des Quinze-Vingts | Paris | 75012 | France |
| Knapschaftskrankenhaus Bochum Langendreer | Bochum | 44892 | Germany |
| Helios Cliniic | Erfurt | 99089 | Germany |
| Universitatsklinkum Erlangen | Erlangen | Germany |
| AHEPA Hospital | Thessaloniki | 546 36 | Greece |
| Universita'degli Studi di Parma | Parma | 43100 | Italy |
| Universita' di Torino/Dipartimento di Fisiopatologia Clinica-Clinica Oculistica | Torino | 10128 | Italy |
| Azienda Ospedaliera S. Maria della Misericordia | Udine | 33100 | Italy |
| Military Health Service Institute | Warsaw | 00-909 | Poland |
| Hospital Torrevieja Salud, UTE | Alicante | 03186 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | Spain |
| Hinchingbrooke Hospital Moorfields | Bedford | United Kingdom |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D005902 | Glaucoma, Open-Angle |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
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| ID | Term |
|---|---|
| D015607 | Stents |
| D000077338 | Latanoprost |
| D013999 | Timolol |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009025 | Morpholines |
| D010078 | Oxazines |
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