Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy

• Sponsor: University of Toronto (Other)
• Overall Status: Completed
• CT.gov ID: NCT01263561
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Arms: 2
• Duration (Months): 48
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Procedure: ExPRESS shunt; Procedure: trabeculectomy	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy
• Study Start Date: Apr 1, 2009
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: trabeculectomy trabeculectomy filtering surgery	Procedure: trabeculectomy; trabeculectomy filtering surgery
Experimental: ExPRESS ExPRESS miniature glaucoma drainage device	Procedure: ExPRESS shunt; ExPRESS miniature glaucoma drainage device

Outcome Measures

Primary Outcome Measures

1. Intraocular Pressure [1 year post surgery]

2. Success Rate (IOP Between 5-18 mmHg and 20% Reduction From Baseline) Without Glaucoma Medication [1 year post surgery]

Secondary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Ophthalmology and Vision Sciences Toronto Westarn Hospital	Toronto	Ontario	Canada	M5T 2S8

Sponsors and Collaborators

• University of Toronto

Investigators

• Study Director: Graham E Trope, Professor, University of Toronto
• Study Director: Yvonne M Buys, Professor, University of Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yvonne Buys, MD, FRCSC; Professor, University of Toronto
• ClinicalTrials.gov Identifier: NCT01263561
• Other Study ID Numbers: 07-0888-A
• First Posted: Dec 20, 2010
• Last Update Posted: Dec 9, 2014
• Last Verified: Dec 1, 2014

• Keywords provided by Yvonne Buys, MD, FRCSC; Professor, University of Toronto: glaucoma; filtration surgery; trabeculectomy; ExPRESS shunt
• Additional relevant MeSH terms: Glaucoma

Study Results

Participant Flow

Arm/Group Title	Trabeculectomy	ExPRESS
Arm/Group Description	trabeculectomy filtering surgery trabeculectomy: trabeculectomy filtering surgery	ExPRESS miniature glaucoma drainage device ExPRESS shunt: ExPRESS miniature glaucoma drainage device
Period Title: Overall Study
STARTED	31	33
COMPLETED	30	31
NOT COMPLETED	1	2

Baseline Characteristics

Arm/Group Title	Trabeculectomy	ExPRESS	Total
Arm/Group Description	trabeculectomy filtering surgery trabeculectomy: trabeculectomy filtering surgery	ExPRESS miniature glaucoma drainage device ExPRESS shunt: ExPRESS miniature glaucoma drainage device	Total of all reporting groups
Overall Participants	31	33	64
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.9 (11.5)	62 (13.9)	63.9 (12.7)
Sex: Female, Male (Count of Participants)
Female	10 32.3%	13 39.4%	23 35.9%
Male	21 67.7%	20 60.6%	41 64.1%
intraocular pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	22 (6.8)	22.6 (10.2)	22.3 (8.6)
glaucoma medications (number of medications) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [number of medications]	3.4 (1.3)	3.5 (.9)	3.5 (1.1)
visual acuity (logMAR) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [logMAR]	.48 (.6)	.42 (.6)	.44 (.56)

Outcome Measures

1. Primary Outcome

Title	Intraocular Pressure
Time Frame	1 year post surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Trabeculectomy	ExPRESS
Arm/Group Description	trabeculectomy filtering surgery trabeculectomy: trabeculectomy filtering surgery	ExPRESS miniature glaucoma drainage device ExPRESS shunt: ExPRESS miniature glaucoma drainage device
Measure Participants	30	31
Mean (Standard Deviation) [mmHg]	10.7 (3.5)	11.2 (4.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Trabeculectomy, ExPRESS
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A sample size calculation determined that 52 eyes were required to detect a 2.0 mmHg IOP difference with a power of 80%.
Statistical Test of Hypothesis	p-Value	.85
	Comments
	Method	t-test, 2 sided
	Comments

2. Primary Outcome

Title	Success Rate (IOP Between 5-18 mmHg and 20% Reduction From Baseline) Without Glaucoma Medication
Time Frame	1 year post surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Trabeculectomy	ExPRESS
Arm/Group Description	trabeculectomy filtering surgery trabeculectomy: trabeculectomy filtering surgery	ExPRESS miniature glaucoma drainage device ExPRESS shunt: ExPRESS miniature glaucoma drainage device
Measure Participants	30	31
Number [percentage of participants]	57 183.9%	71 215.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Trabeculectomy, ExPRESS
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Power calculation only for main outcome measure of IOP.
Statistical Test of Hypothesis	p-Value	.24
	Comments
	Method	Kaplan Meier
	Comments

3. Secondary Outcome

Title	Complications
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.
Time Frame	1 year post surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Trabeculectomy	ExPRESS
Arm/Group Description	trabeculectomy filtering surgery trabeculectomy: trabeculectomy filtering surgery	ExPRESS miniature glaucoma drainage device ExPRESS shunt: ExPRESS miniature glaucoma drainage device
Measure Participants	31	33
Early transient hypotony	12 38.7%	13 39.4%
Late transient hypotony	2 6.5%	3 9.1%
encapsulated bleb	1 3.2%	0 0%
choroidal effusion	1 3.2%	0 0%
early bleb leak	2 6.5%	3 9.1%
membrane over ExPRESS	0 0%	1 3%
ExPRESS eroding through sclera	0 0%	1 3%
Total # of subjects with a complication	16 51.6%	15 45.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Trabeculectomy, ExPRESS
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Power calculation only performed for main outcome measure of IOP.
Statistical Test of Hypothesis	p-Value	0.80
	Comments	Above p is for number of subjects with any complication. P values above 0.05 are considered statistically insignificant in this study.
	Method	Chi-squared
	Comments

Adverse Events

Time Frame	1 year
Arm/Group Title	Trabeculectomy		ExPRESS
Arm/Group Description	trabeculectomy filtering surgery trabeculectomy: trabeculectomy filtering surgery		ExPRESS miniature glaucoma drainage device ExPRESS shunt: ExPRESS miniature glaucoma drainage device
All Cause Mortality
	Trabeculectomy		ExPRESS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Trabeculectomy		ExPRESS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/33 (0%)
Other (Not Including Serious) Adverse Events
	Trabeculectomy		ExPRESS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/33 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.