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Prospective randomized study comparing guarded Ex-PRESS to trabeculectomy. Primary outcome: IOP and success (complete success defined as IOP between 5-18 mmHg and 20% reduction from baseline without medication or additional glaucoma surgery and qualified success defined as IOP between 5-18 mmHg and 20% reduction from baseline with or without glaucoma medication but no additional glaucoma surgery). Secondary outcomes: number of glaucoma medications, visual acuity, number of complications, corneal pachymetry and corneal endothelial cell counts.
Complications will be evaluated for the intra-operative, early post-operative (up until 1 month) and late post-operative (from 1 month to 1 year) periods. In addition complications will be evaluated as severe (defined as a permanent reduction in vision or complications requiring a surgical intervention) and not severe (complications which resolve with conservative management). As an individual subject may have more than one complication, the number of complications will be compared between the two surgical groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| trabeculectomy | Active Comparator | trabeculectomy filtering surgery |
|
| ExPRESS | Experimental | ExPRESS miniature glaucoma drainage device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ExPRESS shunt | Procedure | ExPRESS miniature glaucoma drainage device |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure | 1 year post surgery | |
| Success Rate (IOP Between 5-18 mmHg and 20% Reduction From Baseline) Without Glaucoma Medication | 1 year post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Complications will be evaluated for the intra-operative, early post-operative (up until 1 month) and late post-operative (from 1 month to 1 year) periods. In addition complications will be evaluated as severe (defined as a permanent reduction in vision or complications requiring a surgical intervention) and not severe (complications which resolve with conservative management). As an individual subject may have more than one complication, the number of complications will be compared between the two surgical groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Graham E Trope, Professor | University of Toronto | Study Director |
| Yvonne M Buys, Professor | University of Toronto | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology and Vision Sciences Toronto Westarn Hospital | Toronto | Ontario | M5T 2S8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36912740 | Derived | 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. | |
| 26674779 | Derived | Gonzalez-Rodriguez JM, Trope GE, Drori-Wagschal L, Jinapriya D, Buys YM. Comparison of trabeculectomy versus Ex-PRESS: 3-year follow-up. Br J Ophthalmol. 2016 Sep;100(9):1269-73. doi: 10.1136/bjophthalmol-2015-307161. Epub 2015 Dec 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Trabeculectomy | trabeculectomy filtering surgery trabeculectomy: trabeculectomy filtering surgery |
| FG001 | ExPRESS | ExPRESS miniature glaucoma drainage device ExPRESS shunt: ExPRESS miniature glaucoma drainage device |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Trabeculectomy | trabeculectomy filtering surgery trabeculectomy: trabeculectomy filtering surgery |
| BG001 | ExPRESS | ExPRESS miniature glaucoma drainage device ExPRESS shunt: ExPRESS miniature glaucoma drainage device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Intraocular Pressure | Posted | Mean | Standard Deviation | mmHg | 1 year post surgery |
|
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Trabeculectomy | trabeculectomy filtering surgery trabeculectomy: trabeculectomy filtering surgery |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Yvonne Buys | Department of Ophthalmology and Vision Sciences, University of Toronto | 416-603-5682 | y.buys@utoronto.ca |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014130 | Trabeculectomy |
| ID | Term |
|---|---|
| D018463 | Filtering Surgery |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| trabeculectomy |
| Procedure |
trabeculectomy filtering surgery |
|
| 1 year post surgery |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| intraocular pressure | Mean | Standard Deviation | mmHg |
|
| glaucoma medications | Mean | Standard Deviation | number of medications |
|
| visual acuity | Mean | Standard Deviation | logMAR |
|
|
|
| Primary | Success Rate (IOP Between 5-18 mmHg and 20% Reduction From Baseline) Without Glaucoma Medication | Posted | Number | percentage of participants | 1 year post surgery |
|
|
|
|
| Secondary | Complications | Complications will be evaluated for the intra-operative, early post-operative (up until 1 month) and late post-operative (from 1 month to 1 year) periods. In addition complications will be evaluated as severe (defined as a permanent reduction in vision or complications requiring a surgical intervention) and not severe (complications which resolve with conservative management). As an individual subject may have more than one complication, the number of complications will be compared between the two surgical groups. | Posted | Number | participants | 1 year post surgery |
|
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | ExPRESS | ExPRESS miniature glaucoma drainage device ExPRESS shunt: ExPRESS miniature glaucoma drainage device | 0 | 33 | 0 | 33 |
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| encapsulated bleb |
|
| choroidal effusion |
|
| early bleb leak |
|
| membrane over ExPRESS |
|
| ExPRESS eroding through sclera |
|
| Total # of subjects with a complication |
|