Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A prospective randomized trial to compare the safety and efficacy of the Ex-PRESS to trabeculectomy in patients with open angle glaucoma who failed medical or are allergic to medical treatment and for which filtering surgery is indicated. Surgical success was defined as 5 mmHg ≤ intraocular pressure ≤ 18 mmHg, with or without medications, without further glaucoma surgery. Postoperative intraocular pressure, number of medications, complications and success rates were followed for 2 years.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | Active Comparator | Subjects undergoing trabeculectomy with the use of Mitomycin C |
|
| Treatment Arm | Experimental | Subjects undergoing Ex-PRESS Under Scleral Flap implantation procedure with the use of Mitomycin C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trabeculectomy | Procedure | Standard trabeculectomy procedure
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Intraocular Pressure | Mean postoperative intraocular pressure | assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m. 24 months reported |
| Medications | assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m; 24 months reported |
| Measure | Description | Time Frame |
|---|---|---|
| Safety - Incidence of Adverse Events | Comparison of the incidence of all adverse events that occur during the intra-operative and postoperative periods between the two study arms. More than 1 complication may have occurred in the same subject. | 24 months |
| Efficacy - The Number of Participants With Qualified and Complete Success |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter A. Netland, MD, PhD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California | San Francisco | California | 94143-0730 | United States | ||
| University of Florida |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24210765 | Result | Netland PA, Sarkisian SR Jr, Moster MR, Ahmed II, Condon G, Salim S, Sherwood MB, Siegfried CJ. Randomized, prospective, comparative trial of EX-PRESS glaucoma filtration device versus trabeculectomy (XVT study). Am J Ophthalmol. 2014 Feb;157(2):433-440.e3. doi: 10.1016/j.ajo.2013.09.014. Epub 2013 Nov 7. | |
| 36912740 | Derived |
| Label | URL |
|---|---|
| Study results indexed on Pub Med | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Control Arm | Subjects undergoing trabeculectomy with the use of Mitomycin C Trabeculectomy: Standard trabeculectomy procedure
|
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 5, 2011 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Ex-PRESS mini shunt | Device | Ex-PRESS implantation procedure:
|
|
The secondary effectiveness measure will be qualified and complete success rate defined as IOP≤18mmHg with or without medications in the test group as compared to qualified and complete success rate in the concurrent control group at 24 month |
| 24 months |
| Gainesville |
| Florida |
| 32610 |
| United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Dean A. McGee Eye Institute | Oklahoma City | Oklahoma | 73104 | United States |
| Wills EYE Institute | Philadelphia | Pennsylvania | 19066 | United States |
| Allegheny Ophthalmic & Orbital Associates, P.C. | Pittsburgh | Pennsylvania | 15212 | United States |
| University of Tennessee | Memphis | Tennessee | 38163 | United States |
| Osler Eyecare | Mississauga | Ontario | L5B 1N5 | Canada |
| Park J, Rittiphairoj T, Wang X, E JY, Bicket AK. Device-modified trabeculectomy for glaucoma. Cochrane Database Syst Rev. 2023 Mar 13;3(3):CD010472. doi: 10.1002/14651858.CD010472.pub3. |
| FG001 | Treatment Arm | Subjects undergoing Ex-PRESS Under Scleral Flap implantation procedure with the use of Mitomycin C Ex-PRESS mini shunt: Ex-PRESS implantation procedure:
|
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control Arm | Subjects undergoing trabeculectomy with the use of Mitomycin C Trabeculectomy: Standard trabeculectomy procedure
|
| BG001 | Treatment Arm | Subjects undergoing Ex-PRESS Under Scleral Flap implantation procedure with the use of Mitomycin C Ex-PRESS mini shunt: Ex-PRESS implantation procedure:
|
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postoperative Intraocular Pressure | Mean postoperative intraocular pressure | Posted | Mean | Standard Deviation | mmHg | assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m. 24 months reported | eyes | eyes |
|
|
| |||||||||||||||||||||||||||||
| Primary | Medications | Posted | Mean | Standard Deviation | number of medications | assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m; 24 months reported | eyes | eyes |
|
| |||||||||||||||||||||||||||||||
| Secondary | Safety - Incidence of Adverse Events | Comparison of the incidence of all adverse events that occur during the intra-operative and postoperative periods between the two study arms. More than 1 complication may have occurred in the same subject. | Posted | Number | complications | 24 months | eyes | eyes |
| ||||||||||||||||||||||||||||||||
| Secondary | Efficacy - The Number of Participants With Qualified and Complete Success | The secondary effectiveness measure will be qualified and complete success rate defined as IOP≤18mmHg with or without medications in the test group as compared to qualified and complete success rate in the concurrent control group at 24 month | Posted | Number | participants | 24 months | eyes | eyes |
|
2 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Arm | Subjects undergoing trabeculectomy with the use of Mitomycin C | 0 | 61 | 22 | 61 | ||
| EG001 | Treatment Arm | Subjects undergoing Ex-PRESS Under Scleral Flap implantation procedure with the use of Mitomycin C | 0 | 59 | 9 | 59 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Shallow anterior chamber | Eye disorders | Non-systematic Assessment |
| ||
| Surgically treated cataract | Eye disorders | Non-systematic Assessment |
| ||
| Hyphema | Eye disorders | Non-systematic Assessment |
| ||
| Early wound leak | Eye disorders | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter A. Netland, MD, PhD | University of Virginia | 434-982-1086 | pan9c@virginia.edu |
| Aug 26, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014130 | Trabeculectomy |
| ID | Term |
|---|---|
| D018463 | Filtering Surgery |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Canada |
|
| eyes |
|
|
|
|
|
|
|