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Patient population limited
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| Name | Class |
|---|---|
| Optonol | UNKNOWN |
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The less invasive nature of the Ex-Press Mini shunt with mitomycin C induces less post-operative inflammation than trabeculectomy with mitomycin c.
The purpose of this study is to quantify the degree of post-operative inflammation in eyes which have undergone either trabeculectomy filtering surgery or Ex-Press mini shunt insertion. Early intraocular pressure control and postoperative complications will also be noted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Trabeculectomy with Mitomycin C 0.2 mg/cc for 2 minutes |
|
| 2 | Active Comparator | Ex-Press mini shunt; Model R50 with mitomycin C 0.2 mg/cc for 2 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trabeculectomy with mitomycin c | Procedure | mitomycin c 0.2 mg/cc for 2 minutes |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Aqueous humor flare | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Aqueous humor cell | 2 months |
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Inclusion Criteria:
All subjects must:
Exclusion Criteria:
No subject may:
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| Name | Affiliation | Role |
|---|---|---|
| Louis B Cantor, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IU Eye at Carmel | Indianapolis | Indiana | 46290 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11220271 | Background | Hille K, Hans J, Manderscheid T, Spang S, Ruprecht KW. [Laser flare in combined cataract and glaucoma surgery]. Ophthalmologe. 2001 Jan;98(1):47-53. doi: 10.1007/s003470170199. German. | |
| 17224744 | Background | Maris PJ Jr, Ishida K, Netland PA. Comparison of trabeculectomy with Ex-PRESS miniature glaucoma device implanted under scleral flap. J Glaucoma. 2007 Jan;16(1):14-9. doi: 10.1097/01.ijg.0000243479.90403.cd. |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014130 | Trabeculectomy |
| D016685 | Mitomycin |
| ID | Term |
|---|---|
| D018463 | Filtering Surgery |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008937 | Mitomycins |
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| Ex-Press mini shunt with mitomycin c |
| Procedure |
mitomycin c 0.2 mg/cc for 2 minutes |
|
| 8407220 | Background | Shah SM, Spalton DJ, Allen RJ, Smith SE. A comparison of the laser flare cell meter and fluorophotometry in assessment of the blood-aqueous barrier. Invest Ophthalmol Vis Sci. 1993 Oct;34(11):3124-30. |
| 15741808 | Background | Dahan E, Carmichael TR. Implantation of a miniature glaucoma device under a scleral flap. J Glaucoma. 2005 Apr;14(2):98-102. doi: 10.1097/01.ijg.0000151688.34904.b7. |
| Background | Shields, MB Textbook of Glaucoma. Fourth Edition; Williams & Wilkins, Baltimore, 1998. |
| Background | Guyer DR, Yannuzzi LA, Chang S, Shields JA, Green WR Retina-Vitreous-Macula. W.B. Saunders Company, Philadelphia, 1999. |
| D045563 | Indolequinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
| D001389 | Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |