Trial Outcomes & Findings for Comparison of Ex-PRESSTM Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open Angle Glaucoma (NCT NCT00444080)
NCT ID: NCT00444080
Last Updated: 2020-10-14
Results Overview
Mean postoperative intraocular pressure
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m. 24 months reported
Results posted on
2020-10-14
Participant Flow
Participant milestones
| Measure |
Control Arm
Subjects undergoing trabeculectomy with the use of Mitomycin C
Trabeculectomy: Standard trabeculectomy procedure
1. Creation of a fornix or limbal based conjunctival flap in upper quadrants
2. Creation of a limbal-based scleral flap extending into clear cornea
3. Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes)
4. Creation of fistula 1mm x 2mm in size
5. Iridectomy
6. Suturing the scleral flap
7. Repositioning of conjunctiva with sutures After procedure, antibiotics \& steroids are administered topically; eye is covered with a pad - patient is discharged.
|
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:
1. Creation of a fornix or limbal based conjunctival flap in upper quadrants
2. Creation of limbal-based scleral flap extending into clear cornea
3. Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes)
4. 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
5. Prior to implantation, a thorough mobility check should be performed
6. Implantation of Ex-PRESS implant loaded on its introducer, through that pre-incision
7. Withdrawal of introducer
8. Tucking plate under the scleral flap, and verification of its position
9. Suturing scleral flap After implantation procedure, antibiotics \& steroids administered topically; eye is covered with a pad.
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
59
|
|
Overall Study
COMPLETED
|
61
|
59
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Ex-PRESSTM Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open Angle Glaucoma
Baseline characteristics by cohort
| Measure |
Control Arm
n=61 Participants
Subjects undergoing trabeculectomy with the use of Mitomycin C
Trabeculectomy: Standard trabeculectomy procedure
1. Creation of a fornix or limbal based conjunctival flap in upper quadrants
2. Creation of a limbal-based scleral flap extending into clear cornea
3. Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes)
4. Creation of fistula 1mm x 2mm in size
5. Iridectomy
6. Suturing the scleral flap
7. Repositioning of conjunctiva with sutures After procedure, antibiotics \& steroids are administered topically; eye is covered with a pad - patient is discharged.
|
Treatment Arm
n=59 Participants
Subjects undergoing Ex-PRESS Under Scleral Flap implantation procedure with the use of Mitomycin C
Ex-PRESS mini shunt: Ex-PRESS implantation procedure:
1. Creation of a fornix or limbal based conjunctival flap in upper quadrants
2. Creation of limbal-based scleral flap extending into clear cornea
3. Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes)
4. 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
5. Prior to implantation, a thorough mobility check should be performed
6. Implantation of Ex-PRESS implant loaded on its introducer, through that pre-incision
7. Withdrawal of introducer
8. Tucking plate under the scleral flap, and verification of its position
9. Suturing scleral flap After implantation procedure, antibiotics \& steroids administered topically; eye is covered with a pad.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=39 Participants
|
23 Participants
n=41 Participants
|
48 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
36 Participants
n=39 Participants
|
36 Participants
n=41 Participants
|
72 Participants
n=35 Participants
|
|
Age, Continuous
|
69.4 years
STANDARD_DEVIATION 11.6 • n=39 Participants
|
67.8 years
STANDARD_DEVIATION 10.4 • n=41 Participants
|
68.6 years
STANDARD_DEVIATION 11.0 • n=35 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=39 Participants
|
27 Participants
n=41 Participants
|
55 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=39 Participants
|
32 Participants
n=41 Participants
|
65 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=39 Participants
|
52 participants
n=41 Participants
|
107 participants
n=35 Participants
|
|
Region of Enrollment
Canada
|
6 participants
n=39 Participants
|
7 participants
n=41 Participants
|
13 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m. 24 months reportedMean postoperative intraocular pressure
Outcome measures
| Measure |
Control Arm
n=61 eyes
Subjects undergoing trabeculectomy with the use of Mitomycin C
Trabeculectomy: Standard trabeculectomy procedure
1. Creation of a fornix or limbal based conjunctival flap in upper quadrants
2. Creation of a limbal-based scleral flap extending into clear cornea
3. Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes)
4. Creation of fistula 1mm x 2mm in size
5. Iridectomy
6. Suturing the scleral flap
7. Repositioning of conjunctiva with sutures After procedure, antibiotics \& steroids are administered topically; eye is covered with a pad - patient is discharged.
|
Treatment Arm
n=59 eyes
Subjects undergoing Ex-PRESS Under Scleral Flap implantation procedure with the use of Mitomycin C
Ex-PRESS mini shunt procedure:
1. Creation of a fornix or limbal based conjunctival flap in upper quadrants
2. Creation of limbal-based scleral flap extending into clear cornea
3. Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes)
4. 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
5. Prior to implantation, a thorough mobility check should be performed
6. Implantation of Ex-PRESS implant loaded on its introducer, through that pre-incision
7. Withdrawal of introducer
8. Tucking plate under the scleral flap, and verification of its position
9. Suturing scleral flap After implantation procedure, antibiotics \& steroids administered topically; eye is covered with a pad - patient is discharged.
|
|---|---|---|
|
Postoperative Intraocular Pressure
|
14.6 mmHg
Standard Deviation 7.1
|
14.7 mmHg
Standard Deviation 4.6
|
PRIMARY outcome
Timeframe: assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m; 24 months reportedOutcome measures
| Measure |
Control Arm
n=61 eyes
Subjects undergoing trabeculectomy with the use of Mitomycin C
Trabeculectomy: Standard trabeculectomy procedure
1. Creation of a fornix or limbal based conjunctival flap in upper quadrants
2. Creation of a limbal-based scleral flap extending into clear cornea
3. Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes)
4. Creation of fistula 1mm x 2mm in size
5. Iridectomy
6. Suturing the scleral flap
7. Repositioning of conjunctiva with sutures After procedure, antibiotics \& steroids are administered topically; eye is covered with a pad - patient is discharged.
|
Treatment Arm
n=59 eyes
Subjects undergoing Ex-PRESS Under Scleral Flap implantation procedure with the use of Mitomycin C
Ex-PRESS mini shunt procedure:
1. Creation of a fornix or limbal based conjunctival flap in upper quadrants
2. Creation of limbal-based scleral flap extending into clear cornea
3. Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes)
4. 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
5. Prior to implantation, a thorough mobility check should be performed
6. Implantation of Ex-PRESS implant loaded on its introducer, through that pre-incision
7. Withdrawal of introducer
8. Tucking plate under the scleral flap, and verification of its position
9. Suturing scleral flap After implantation procedure, antibiotics \& steroids administered topically; eye is covered with a pad - patient is discharged.
|
|---|---|---|
|
Medications
|
0.7 number of medications
Standard Deviation 1.2
|
0.9 number of medications
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 24 monthsComparison 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.
Outcome measures
| Measure |
Control Arm
n=61 eyes
Subjects undergoing trabeculectomy with the use of Mitomycin C
Trabeculectomy: Standard trabeculectomy procedure
1. Creation of a fornix or limbal based conjunctival flap in upper quadrants
2. Creation of a limbal-based scleral flap extending into clear cornea
3. Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes)
4. Creation of fistula 1mm x 2mm in size
5. Iridectomy
6. Suturing the scleral flap
7. Repositioning of conjunctiva with sutures After procedure, antibiotics \& steroids are administered topically; eye is covered with a pad - patient is discharged.
|
Treatment Arm
n=59 eyes
Subjects undergoing Ex-PRESS Under Scleral Flap implantation procedure with the use of Mitomycin C
Ex-PRESS mini shunt procedure:
1. Creation of a fornix or limbal based conjunctival flap in upper quadrants
2. Creation of limbal-based scleral flap extending into clear cornea
3. Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes)
4. 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
5. Prior to implantation, a thorough mobility check should be performed
6. Implantation of Ex-PRESS implant loaded on its introducer, through that pre-incision
7. Withdrawal of introducer
8. Tucking plate under the scleral flap, and verification of its position
9. Suturing scleral flap After implantation procedure, antibiotics \& steroids administered topically; eye is covered with a pad - patient is discharged.
|
|---|---|---|
|
Safety - Incidence of Adverse Events
|
25 complications
|
11 complications
|
SECONDARY outcome
Timeframe: 24 monthsThe 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
Outcome measures
| Measure |
Control Arm
n=61 eyes
Subjects undergoing trabeculectomy with the use of Mitomycin C
Trabeculectomy: Standard trabeculectomy procedure
1. Creation of a fornix or limbal based conjunctival flap in upper quadrants
2. Creation of a limbal-based scleral flap extending into clear cornea
3. Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes)
4. Creation of fistula 1mm x 2mm in size
5. Iridectomy
6. Suturing the scleral flap
7. Repositioning of conjunctiva with sutures After procedure, antibiotics \& steroids are administered topically; eye is covered with a pad - patient is discharged.
|
Treatment Arm
n=59 eyes
Subjects undergoing Ex-PRESS Under Scleral Flap implantation procedure with the use of Mitomycin C
Ex-PRESS mini shunt procedure:
1. Creation of a fornix or limbal based conjunctival flap in upper quadrants
2. Creation of limbal-based scleral flap extending into clear cornea
3. Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes)
4. 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
5. Prior to implantation, a thorough mobility check should be performed
6. Implantation of Ex-PRESS implant loaded on its introducer, through that pre-incision
7. Withdrawal of introducer
8. Tucking plate under the scleral flap, and verification of its position
9. Suturing scleral flap After implantation procedure, antibiotics \& steroids administered topically; eye is covered with a pad - patient is discharged.
|
|---|---|---|
|
Efficacy - The Number of Participants With Qualified and Complete Success
|
48 participants
|
49 participants
|
Adverse Events
Control Arm
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Treatment Arm
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control Arm
n=61 participants at risk
Subjects undergoing trabeculectomy with the use of Mitomycin C
|
Treatment Arm
n=59 participants at risk
Subjects undergoing Ex-PRESS Under Scleral Flap implantation procedure with the use of Mitomycin C
|
|---|---|---|
|
Eye disorders
Shallow anterior chamber
|
11.5%
7/61 • Number of events 7 • 2 years
|
6.8%
4/59 • Number of events 4 • 2 years
|
|
Eye disorders
Surgically treated cataract
|
11.5%
7/61 • Number of events 7 • 2 years
|
5.1%
3/59 • Number of events 3 • 2 years
|
|
Eye disorders
Hyphema
|
9.8%
6/61 • Number of events 6 • 2 years
|
0.00%
0/59 • 2 years
|
|
Eye disorders
Early wound leak
|
4.9%
3/61 • Number of events 3 • 2 years
|
3.4%
2/59 • Number of events 2 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place