Glaucoma
Conditions
Keywords
glaucoma, filtration surgery, trabeculectomy, ExPRESS shunt
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREExPRESS shunt
ExPRESS miniature glaucoma drainage device
PROCEDUREtrabeculectomy
trabeculectomy filtering surgery
Sponsors
University of Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* age 18 to 85 * open-angle glaucoma uncontrolled medically * intraocular pressure ≥ 18 mmHg * trabeculectomy as the planned surgical procedure
Exclusion criteria
* any previous ocular incisional surgery with the exception of previous clear * cornea cataract surgery * uveitis * vitreous present in anterior chamber * patient unwilling or unable to accept randomization or to give consent or to attend the follow up visits
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications | 1 year post surgery | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Trabeculectomy trabeculectomy filtering surgery
trabeculectomy: trabeculectomy filtering surgery | 31 |
| ExPRESS ExPRESS miniature glaucoma drainage device
ExPRESS shunt: ExPRESS miniature glaucoma drainage device | 33 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 2 |
Baseline characteristics
| Characteristic | Trabeculectomy | ExPRESS | Total |
|---|---|---|---|
| Age, Continuous | 65.9 years STANDARD_DEVIATION 11.5 | 62 years STANDARD_DEVIATION 13.9 | 63.9 years STANDARD_DEVIATION 12.7 |
| glaucoma medications | 3.4 number of medications STANDARD_DEVIATION 1.3 | 3.5 number of medications STANDARD_DEVIATION 0.9 | 3.5 number of medications STANDARD_DEVIATION 1.1 |
| intraocular pressure | 22 mmHg STANDARD_DEVIATION 6.8 | 22.6 mmHg STANDARD_DEVIATION 10.2 | 22.3 mmHg STANDARD_DEVIATION 8.6 |
| Sex: Female, Male Female | 10 Participants | 13 Participants | 23 Participants |
| Sex: Female, Male Male | 21 Participants | 20 Participants | 41 Participants |
| visual acuity | .48 logMAR STANDARD_DEVIATION 0.6 | .42 logMAR STANDARD_DEVIATION 0.6 | .44 logMAR STANDARD_DEVIATION 0.56 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 31 | 0 / 33 |
| serious Total, serious adverse events | 0 / 31 | 0 / 33 |
Outcome results
Primary
Intraocular Pressure
Time frame: 1 year post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trabeculectomy | Intraocular Pressure | 10.7 mmHg | Standard Deviation 3.5 |
| ExPRESS | Intraocular Pressure | 11.2 mmHg | Standard Deviation 4.3 |
p-value: 0.85t-test, 2 sided
Primary
Success Rate (IOP Between 5-18 mmHg and 20% Reduction From Baseline) Without Glaucoma Medication
Time frame: 1 year post surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trabeculectomy | Success Rate (IOP Between 5-18 mmHg and 20% Reduction From Baseline) Without Glaucoma Medication | 57 percentage of participants |
| ExPRESS | Success Rate (IOP Between 5-18 mmHg and 20% Reduction From Baseline) Without Glaucoma Medication | 71 percentage of participants |
p-value: 0.24Kaplan Meier
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.
Time frame: 1 year post surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trabeculectomy | Complications | choroidal effusion | 1 participants |
| Trabeculectomy | Complications | Early transient hypotony | 12 participants |
| Trabeculectomy | Complications | Late transient hypotony | 2 participants |
| Trabeculectomy | Complications | encapsulated bleb | 1 participants |
| Trabeculectomy | Complications | early bleb leak | 2 participants |
| Trabeculectomy | Complications | membrane over ExPRESS | 0 participants |
| Trabeculectomy | Complications | ExPRESS eroding through sclera | 0 participants |
| Trabeculectomy | Complications | Total # of subjects with a complication | 16 participants |
| ExPRESS | Complications | Total # of subjects with a complication | 15 participants |
| ExPRESS | Complications | early bleb leak | 3 participants |
| ExPRESS | Complications | Early transient hypotony | 13 participants |
| ExPRESS | Complications | ExPRESS eroding through sclera | 1 participants |
| ExPRESS | Complications | Late transient hypotony | 3 participants |
| ExPRESS | Complications | membrane over ExPRESS | 1 participants |
| ExPRESS | Complications | encapsulated bleb | 0 participants |
| ExPRESS | Complications | choroidal effusion | 0 participants |
p-value: 0.8Chi-squared