Comparison of Ex-PRESSTM Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open Angle Glaucoma

• Sponsor: University of Virginia (Other)
• Overall Status: Completed
• CT.gov ID: NCT00444080
• Collaborator: (none)
• Enrollment: 120
• Locations: 8
• Arms: 2
• Duration (Months): 63
• Patients Per Site: 15
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Procedure: Trabeculectomy; Device: Ex-PRESS mini shunt	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multi Center Study Comparing the Ex-PRESSTM Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open Angle Glaucoma
• Study Start Date: Oct 1, 2006
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Arm Subjects undergoing trabeculectomy with the use of Mitomycin C	Procedure: Trabeculectomy; Standard trabeculectomy procedure Creation of a fornix or limbal based conjunctival flap in upper quadrants Creation of a limbal-based scleral flap extending into clear cornea Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes) Creation of fistula 1mm x 2mm in size Iridectomy Suturing the scleral flap Repositioning of conjunctiva with sutures After procedure, antibiotics & steroids are administered topically; eye is covered with a pad - patient is discharged.
Experimental: Treatment Arm Subjects undergoing Ex-PRESS Under Scleral Flap implantation procedure with the use of Mitomycin C	Device: Ex-PRESS mini shunt; Ex-PRESS implantation procedure: Creation of a fornix or limbal based conjunctival flap in upper quadrants Creation of limbal-based scleral flap extending into clear cornea Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes) Penetration into anterior chamber using 23-25G needle, halfway between the white sclera and clear cornea (in the center of the grey zone);creation of track incision at limbus Prior to implantation, a thorough mobility check should be performed Implantation of Ex-PRESS implant loaded on its introducer, through that pre-incision Withdrawal of introducer Tucking plate under the scleral flap, and verification of its position Suturing scleral flap After implantation procedure, antibiotics & steroids administered topically; eye is covered with a pad - patient is discharged.

Outcome Measures

Primary Outcome Measures

1. Postoperative Intraocular Pressure [assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m. 24 months reported]

   Mean postoperative intraocular pressure

2. Medications [assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m; 24 months reported]

Secondary Outcome Measures

1. Safety - Incidence of Adverse Events [24 months]

   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.

2. Efficacy - The Number of Participants With Qualified and Complete Success [24 months]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult subject over the age of 18

• Subject diagnosed with open angle glaucoma (POAG, PXFG or PDSG) or ocular hypertension

• Subject is a candidate for filtering surgery with intraoperative anti-metabolites

• IOP > 18 mmHg on maximum tolerated medial therapy based on two measurements taken 1 hour apart at the same visit.

• Subject willing to attend all follow-up evaluations

• Subject willing to sign informed consent.

Exclusion Criteria:

• Subject diagnosed with: PACG, NTG, secondary glaucoma, neovascular glaucoma

• Subject has history of glaucoma surgery (filtering, glaucoma drainage device, cyclo destructive procedures)

• Subject has history of penetrating keratoplasty (PKP)

• Subject underwent large incision extra capsular cataract extraction

• Subject had cataract phacoemulsification within the last month

• Subject has a visually significant cataract that is planned for extraction at the time of filtering surgery or within 12 months thereafter

• Any ocular disease or history in the operated eye other than glaucoma and cataract, such as uveitis, ocular infection, severe dry eye, severe blepharitis , active proliferative retinopathy, ICE syndrome, epithelial or fibrous down growth, aphakia, and ocular pathology that may interfere with accurate IOP measurements

• Subject has vitreous present in the anterior chamber for which vitrectomy is anticipated

• IOP of ≤18mmHg

• Subject participates in any other concurrent ocular investigation.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California	San Francisco	California	United States	94143-0730
2	University of Florida	Gainesville	Florida	United States	32610
3	Washington University	Saint Louis	Missouri	United States	63110
4	Dean A. McGee Eye Institute	Oklahoma City	Oklahoma	United States	73104
5	Wills EYE Institute	Philadelphia	Pennsylvania	United States	19066
6	Allegheny Ophthalmic & Orbital Associates, P.C.	Pittsburgh	Pennsylvania	United States	15212
7	University of Tennessee	Memphis	Tennessee	United States	38163
8	Osler Eyecare	Mississauga	Ontario	Canada	L5B 1N5

Sponsors and Collaborators

• University of Virginia

Investigators

• Principal Investigator: Peter A. Netland, MD, PhD, University of Virginia

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 5, 2011

More Information

Additional Information:

• Study results indexed on Pub Med

Publications

None provided.

• Responsible Party: Peter Netland, MD, Vernah Scott Moyston Professor, Chair, Department of Ophthalmology, University of Virginia
• ClinicalTrials.gov Identifier: NCT00444080
• Other Study ID Numbers: 14967
• First Posted: Mar 7, 2007
• Last Update Posted: Oct 14, 2020
• Last Verified: Sep 1, 2020

• Keywords provided by Peter Netland, MD, Vernah Scott Moyston Professor, Chair, Department of Ophthalmology, University of Virginia: Ex-PRESS; TRABECULECTOMY
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle

Study Results

Participant Flow

Arm/Group Title	Control Arm	Treatment Arm
Arm/Group Description	Subjects undergoing trabeculectomy with the use of Mitomycin C Trabeculectomy: Standard trabeculectomy procedure Creation of a fornix or limbal based conjunctival flap in upper quadrants Creation of a limbal-based scleral flap extending into clear cornea Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes) Creation of fistula 1mm x 2mm in size Iridectomy Suturing the scleral flap Repositioning of conjunctiva with sutures After procedure, antibiotics & steroids are administered topically; eye is covered with a pad - patient is discharged.	Subjects undergoing Ex-PRESS Under Scleral Flap implantation procedure with the use of Mitomycin C Ex-PRESS mini shunt: Ex-PRESS implantation procedure: Creation of a fornix or limbal based conjunctival flap in upper quadrants Creation of limbal-based scleral flap extending into clear cornea Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes) Penetration into anterior chamber using 23-25G needle, halfway between the white sclera and clear cornea (in the center of the grey zone);creation of track incision at limbus Prior to implantation, a thorough mobility check should be performed Implantation of Ex-PRESS implant loaded on its introducer, through that pre-incision Withdrawal of introducer Tucking plate under the scleral flap, and verification of its position Suturing scleral flap After implantation procedure, antibiotics & steroids administered topically; eye is covered with a pad.
Period Title: Overall Study
STARTED	61	59
COMPLETED	61	59
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Control Arm	Treatment Arm	Total
Arm/Group Description	Subjects undergoing trabeculectomy with the use of Mitomycin C Trabeculectomy: Standard trabeculectomy procedure Creation of a fornix or limbal based conjunctival flap in upper quadrants Creation of a limbal-based scleral flap extending into clear cornea Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes) Creation of fistula 1mm x 2mm in size Iridectomy Suturing the scleral flap Repositioning of conjunctiva with sutures After procedure, antibiotics & steroids are administered topically; eye is covered with a pad - patient is discharged.	Subjects undergoing Ex-PRESS Under Scleral Flap implantation procedure with the use of Mitomycin C Ex-PRESS mini shunt: Ex-PRESS implantation procedure: Creation of a fornix or limbal based conjunctival flap in upper quadrants Creation of limbal-based scleral flap extending into clear cornea Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes) Penetration into anterior chamber using 23-25G needle, halfway between the white sclera and clear cornea (in the center of the grey zone);creation of track incision at limbus Prior to implantation, a thorough mobility check should be performed Implantation of Ex-PRESS implant loaded on its introducer, through that pre-incision Withdrawal of introducer Tucking plate under the scleral flap, and verification of its position Suturing scleral flap After implantation procedure, antibiotics & steroids administered topically; eye is covered with a pad.	Total of all reporting groups
Overall Participants	61	59	120
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	25 41%	23 39%	48 40%
>=65 years	36 59%	36 61%	72 60%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.4 (11.6)	67.8 (10.4)	68.6 (11.0)
Sex: Female, Male (Count of Participants)
Female	28 45.9%	27 45.8%	55 45.8%
Male	33 54.1%	32 54.2%	65 54.2%
Region of Enrollment (participants) [Number]
United States	55 90.2%	52 88.1%	107 89.2%
Canada	6 9.8%	7 11.9%	13 10.8%

Outcome Measures

1. Primary Outcome

Title	Postoperative Intraocular Pressure
Description	Mean postoperative intraocular pressure
Time Frame	assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m. 24 months reported

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Arm	Treatment Arm
Arm/Group Description	Subjects undergoing trabeculectomy with the use of Mitomycin C Trabeculectomy: Standard trabeculectomy procedure Creation of a fornix or limbal based conjunctival flap in upper quadrants Creation of a limbal-based scleral flap extending into clear cornea Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes) Creation of fistula 1mm x 2mm in size Iridectomy Suturing the scleral flap Repositioning of conjunctiva with sutures After procedure, antibiotics & steroids are administered topically; eye is covered with a pad - patient is discharged.	Subjects undergoing Ex-PRESS Under Scleral Flap implantation procedure with the use of Mitomycin C Ex-PRESS mini shunt procedure: Creation of a fornix or limbal based conjunctival flap in upper quadrants Creation of limbal-based scleral flap extending into clear cornea Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes) Penetration into anterior chamber using 23-25G needle, halfway between the white sclera and clear cornea (in the center of the grey zone);creation of track incision at limbus Prior to implantation, a thorough mobility check should be performed Implantation of Ex-PRESS implant loaded on its introducer, through that pre-incision Withdrawal of introducer Tucking plate under the scleral flap, and verification of its position Suturing scleral flap After implantation procedure, antibiotics & steroids administered topically; eye is covered with a pad - patient is discharged.
Measure Participants	61	59
Measure eyes	61	59
Mean (Standard Deviation) [mmHg]	14.6 (7.1)	14.7 (4.6)

2. Primary Outcome

Title	Medications
Time Frame	assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m; 24 months reported

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Arm	Treatment Arm
Arm/Group Description	Subjects undergoing trabeculectomy with the use of Mitomycin C	Subjects undergoing Ex-PRESS Under Scleral Flap implantation procedure with the use of Mitomycin C
Measure Participants	61	59
Measure eyes	61	59
Mean (Standard Deviation) [number of medications]	0.7 (1.2)	0.9 (1.3)

3. Secondary Outcome

Title	Safety - Incidence of Adverse Events
Description	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.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Arm	Treatment Arm
Arm/Group Description	Subjects undergoing trabeculectomy with the use of Mitomycin C Trabeculectomy: Standard trabeculectomy procedure Creation of a fornix or limbal based conjunctival flap in upper quadrants Creation of a limbal-based scleral flap extending into clear cornea Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes) Creation of fistula 1mm x 2mm in size Iridectomy Suturing the scleral flap Repositioning of conjunctiva with sutures After procedure, antibiotics & steroids are administered topically; eye is covered with a pad - patient is discharged.	Subjects undergoing Ex-PRESS Under Scleral Flap implantation procedure with the use of Mitomycin C Ex-PRESS mini shunt implantation procedure: Creation of a fornix or limbal based conjunctival flap in upper quadrants Creation of limbal-based scleral flap extending into clear cornea Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes) Penetration into anterior chamber using 23-25G needle, halfway between the white sclera and clear cornea (in the center of the grey zone);creation of track incision at limbus Prior to implantation, a thorough mobility check should be performed Implantation of Ex-PRESS implant loaded on its introducer, through that pre-incision Withdrawal of introducer Tucking plate under the scleral flap, and verification of its position Suturing scleral flap After implantation procedure, antibiotics & steroids administered topically; eye is covered with a pad - patient is discharged.
Measure Participants	61	59
Measure eyes	61	59
Number [complications]	25	11

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Arm, Treatment Arm
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.013
	Comments
	Method	Fisher Exact
	Comments

4. Secondary Outcome

Title	Efficacy - The Number of Participants With Qualified and Complete Success
Description	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
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Arm	Treatment Arm
Arm/Group Description	Subjects undergoing trabeculectomy with the use of Mitomycin C Trabeculectomy: Standard trabeculectomy procedure Creation of a fornix or limbal based conjunctival flap in upper quadrants Creation of a limbal-based scleral flap extending into clear cornea Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes) Creation of fistula 1mm x 2mm in size Iridectomy Suturing the scleral flap Repositioning of conjunctiva with sutures After procedure, antibiotics & steroids are administered topically; eye is covered with a pad - patient is discharged.	Subjects undergoing Ex-PRESS Under Scleral Flap implantation procedure with the use of Mitomycin C Ex-PRESS mini shunt implantation procedure: Creation of a fornix or limbal based conjunctival flap in upper quadrants Creation of limbal-based scleral flap extending into clear cornea Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes) Penetration into anterior chamber using 23-25G needle, halfway between the white sclera and clear cornea (in the center of the grey zone);creation of track incision at limbus Prior to implantation, a thorough mobility check should be performed Implantation of Ex-PRESS implant loaded on its introducer, through that pre-incision Withdrawal of introducer Tucking plate under the scleral flap, and verification of its position Suturing scleral flap After implantation procedure, antibiotics & steroids administered topically; eye is covered with a pad - patient is discharged.
Measure Participants	61	59
Measure eyes	61	59
Number [participants]	48 78.7%	49 83.1%

Adverse Events

Time Frame	2 years
Arm/Group Title	Control Arm		Treatment Arm
Arm/Group Description	Subjects undergoing trabeculectomy with the use of Mitomycin C		Subjects undergoing Ex-PRESS Under Scleral Flap implantation procedure with the use of Mitomycin C
All Cause Mortality
	Control Arm		Treatment Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Control Arm		Treatment Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/61 (0%)		0/59 (0%)
Other (Not Including Serious) Adverse Events
	Control Arm		Treatment Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	22/61 (36.1%)		9/59 (15.3%)
Eye disorders
Shallow anterior chamber	7/61 (11.5%)	7	4/59 (6.8%)	4
Surgically treated cataract	7/61 (11.5%)	7	3/59 (5.1%)	3
Hyphema	6/61 (9.8%)	6	0/59 (0%)	0
Early wound leak	3/61 (4.9%)	3	2/59 (3.4%)	2

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.