Glaucoma
Conditions
Keywords
Ex-PRESS, TRABECULECTOMY
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.
Interventions
PROCEDURETrabeculectomy
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.
DEVICEEx-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 - patient is discharged.
Sponsors
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Intraocular Pressure | assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m. 24 months reported | Mean postoperative intraocular pressure |
| Medications | assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m; 24 months reported | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 61 |
| 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. | 59 |
| Total | 120 |
Baseline characteristics
| Characteristic | Control Arm | Treatment Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 36 Participants | 36 Participants | 72 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 23 Participants | 48 Participants |
| Age, Continuous | 69.4 years STANDARD_DEVIATION 11.6 | 67.8 years STANDARD_DEVIATION 10.4 | 68.6 years STANDARD_DEVIATION 11 |
| Region of Enrollment Canada | 6 participants | 7 participants | 13 participants |
| Region of Enrollment United States | 55 participants | 52 participants | 107 participants |
| Sex: Female, Male Female | 28 Participants | 27 Participants | 55 Participants |
| Sex: Female, Male Male | 33 Participants | 32 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 22 / 61 | 9 / 59 |
| serious Total, serious adverse events | 0 / 61 | 0 / 59 |
Outcome results
Primary
Medications
Time frame: assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m; 24 months reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arm | Medications | 0.7 number of medications | Standard Deviation 1.2 |
| Treatment Arm | Medications | 0.9 number of medications | Standard Deviation 1.3 |
Primary
Postoperative Intraocular Pressure
Mean postoperative intraocular pressure
Time frame: assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m. 24 months reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arm | Postoperative Intraocular Pressure | 14.6 mmHg | Standard Deviation 7.1 |
| Treatment Arm | Postoperative Intraocular Pressure | 14.7 mmHg | Standard Deviation 4.6 |
Secondary
Efficacy - The Number of Participants With Qualified and Complete Success
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Arm | Efficacy - The Number of Participants With Qualified and Complete Success | 48 participants |
| Treatment Arm | Efficacy - The Number of Participants With Qualified and Complete Success | 49 participants |
Secondary
Safety - Incidence of Adverse Events
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Arm | Safety - Incidence of Adverse Events | 25 complications |
| Treatment Arm | Safety - Incidence of Adverse Events | 11 complications |
p-value: 0.013Fisher Exact