Open Angle GlaucomaNCT03201354
Efficacy and Safety of the ExPRESS Implant Versus Deep Sclerectomy in Combined Surgery
A study testing Filtration surgery with Ex-PRESS, Non penetrating deep sclerectomy and Cataract extraction in people with Open Angle Glaucoma and Ocular Hypertension, run by Institut Catala de Retina at 1 site in Spain.
Trial summary
The Ex-PRESS Glaucoma Filtration Device is a small, non-valved implant that was designed to lower intraocular pressure (IOP) by shunting aqueous humor from the anterior chamber into the subconjunctival space. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- Filtration surgery with Ex-PRESS, Non penetrating deep sclerectomy and Cataract extraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2012to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of open-angle glaucoma. Points a, b and c will be required:
- Glaucomatous visual field. Defined as the field presenting at least:
- A group of 3 or more points with p < 5% in the pattern deviation map AND
- One of them with a p < 1% in the pattern deviation map AND
- Repeated in at least 2 VF.
- Glaucomatous optic nerve. Defined as the optic nerve observed in color photographs presenting:
Show all 15Show fewer
- Thinning of the neuroretinal rim that can be demonstrated by an alteration in the ISNT rule.
- Presence of a notch "or"
- Presence of papillary splinter hemorrhage "or"
- Presence of a nerve fiber layer defect "or"
- Cup to disc (C/D) ratio asymmetry > 0.3 that cannot be explained by asymmetry in the optic disc size "or"
- C/D ratio > 0.8 that cannot be explained by a large optic disc size
- III or IV angle in Shaffer classification
- Disease poorly controlled with medical treatment and/or laser at the discretion of the ophthalmologist (progression, higher than targeted pressure, poor compliance…)
- Cataract with visual acuity between 0,1 (20/200) and 0.8 (20/25)
Who cannot join
- Inflammatory, neovasular, closed-angle, normotensive glaucoma secondary to corticoids, or any type of glaucoma with advanced degree of functional lesion (Mean Defect < -20 dB)
- Previous glaucoma surgery
- Previous intraocular ocular surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of the ExPRESS Implant Versus Deep Sclerectomy in Combined Surgery: Prospective, Multi-center, Comparative Study
The Ex-PRESS Glaucoma Filtration Device is a small, non-valved implant that was designed to lower intraocular pressure (IOP) by shunting aqueous humor from the anterior chamber into the subconjunctival space. The implant was developed in response to the need for more straightforward, standardized and safe surgical technique than standard filtration surgery. No iridectomy and no sclerectomy is needed if an Ex-PRESS device is implanted under a partial-thickness scleral flap. This may reduce surgical time and complications when compared to a standard trabeculectomy.
In some studies it has been found to be safe and effective with few complications, even in high-risk patients. No previous studies have compared filtration surgery with Ex-Press implant to deep sclerectomy.
Read the detailed description
Hypothesis:
In combined procedure (cataract and filtering surgery), the effect of Ex-PRESS device has similar efficacy reducing intraocular pressure than non penetrant deep sclerectomy and with good level of safety.
Objective:
To evaluate and compare the efficacy and safety at 12 months of the filtering surgery with the Ex-PRESS device with that of deep sclerectomy.
Methods:
Design: Multi-center, prospective, simple-blind, randomized study.
Primary variable:
- Intraocular pressure.
Secondary variables:
- Success rate at IOP <18
- Frequency and type of complications
- Number of hypotensive drugs needed.
Sample size calculation: Accepting an alfa risk of 0.05 and a beta risk of 0.20 in a two-sided Student's T-test, 50 subjects are necessary in first group and 50 in the second to recognize as statistically significant a difference greater than or equal to 10% in IOP, with a common standard deviation of 17%. A drop-out rate of 8% has been anticipated. If no drop-out rate is considered, the number of needed subjects is 92 (46 per group).
If the drop out rate is more than 8%:
- If the recruitment period is open, another subjects will be included.
- If the recruitment period os close, the inclusion of another subject will be evaluated to maintain the statistic power of the study.
Method
-Single blinded. Each patient will be assigned to one of the two arms (Ex-PRESS or Deep sclerectomy) the same day of surgery. The surgeon will be informed of the randomization result just before surgery by the study coordinator.
Pre-operative examinations:
History summarizing previous surgical procedures, intraocular pressure while on treatment, target pressure at the discretion of the surgeon, visual field (SITA standard 24-2), gonioscopy, and a detailed description of the optic disc / nerve fiber layer by a glaucoma specialist was performed in all subjects included.
Post-operative examinations
Visits were undertaken at 1 day, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months, and 12 months.
Tests:
- visual fields (month 12)
- gonioscopy (month 12)
- intraocular pressure (all visits)
- optic disc examination (all visits, under dilation at 3 and 12 month)
- Pachymetry (preop exam)
- endothelial cell count (months 3 and 12)
- Bleb morphology (month 1 and 12)
- methodic registration of complications (all visits)
A specific CRF was designed with all variables and data required for the study which included a long list of individual potential complications
Pre-operative treatment. Prostaglandin analogues will be discontinued one week before surgery, but the rest of hypotensive drugs will be maintained until the day of surgery
Surgery. Each patient was assigned to one of the two arms (Ex-PRESS or Deep sclerectomy) the same day of surgery. The surgeon wil be informed of the randomization result just before surgery by the study coordinator.
The surgical technique is as follows: retro/peribulbar o subtenon's anesthesia, superior rectus or corneal traction suture, phacoemulsification through 2.1 to 2.8 mm incision with IOL implantation, a fornix-based conjunctival flap, sufficient but not excessive cauterization, application MMC 0,2 mg/ml for 2 minutes under the conjunctiva, then MMC was washed out with 50 ml of saline solution, then and according to the randomization result a scleral flap (5x5 mm in the NPDS, 4x4 mm in the Ex-Press group) is dissected.
Group 1. Then the Ex-PRESS device was placed according to the manufacturer's instructions and its position in the anterior chamber was verified by the surgeon.
Group 2. Deep sclerectomy (NPDS) was performed by dissecting a Deep scleral flap (4x4 mm) and peeling the trabeculo-descement membrane. A Esnoper (AJL, Vitoria, Spain) device was positioned under the external scleral flap and fixated with a 10/0 nylon suture.
Suture Nylon 10/00 suture was used to place four or five stitches in the Ex-Press group and 2 stitches in the NPDS group. Then a hermetic conjunctival suture was performed at the limbus with 10/0 nylon.
Post-operative treatment. All patients instilled Moxifloxacin Antibiotic every 6 hours for 1 week, Dexamethasone (every 2 hours for 1 month, every 4-6 hours on the second month and gradually tapered on the third month according to surgeon's instructions). Atropine was also used at the discretion of the surgeon when clinical finds recommended its use.
Suture lysis or gonio-punture were indicated and performed at the discretion of the surgeon, and they were always registered in the CRF.
Subconjunctival injections of anti-fibrotic agents and/or bleb needling were allowed and performed at the discretion of the surgeon.
DATA ANALYSIS Variables will be checked for normality using the Shapiro-Wilk test. The mean and standard deviation is going to be used to describe normally distributed variables which will be compared between independent groups using the Student t test. Variables that are found to be not normally distributed will be described by median and quartiles, and their comparison between independent groups wil be performed using the Mann-Whitney U test.
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Being tested
- Filtration surgery with Ex-PRESS, Non penetrating deep sclerectomy, Cataract extraction
- Keywords
- Glaucoma, Ocular hypertension, Filtration surgery, Trabeculectomy with Ex-PRESS, Non penetrating deep sclerectomy, Phacoemulsification, Combined surgery
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filtration surgery with Ex-PRESSProcedure or surgery
Filtration surgery with Ex-PRESS
Non penetrating deep sclerectomyProcedure or surgery
Non penetrating deep sclerectomy
Cataract extractionProcedure or surgery
Cataract surgery and IOL implantation
| Study group | Role | What they receive |
|---|---|---|
| Filtration surgery with Express | Active comparator | Filtration surgery with Ex-PRESS + cataract extraction (Cataract surgery and IOL implantation) Receives: Procedure: Filtration surgery with Ex-PRESS; Procedure: Cataract extraction |
| Non penetrating surgery | Active comparator | - Filtration surgery with Non penetrating deep sclerectomy + cataract extraction (Cataract surgery and IOL implantation) Receives: Procedure: Non penetrating deep sclerectomy; Procedure: Cataract extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
mmHg
Measured: Up to 12 months
Secondary outcomes (3)
Success rate at IOP <18
percentage of patients with < of 18 mmHg in intraocular pressure
Measured: Up to 12 months
Number of participants with adverse events assesed by questionare in case report file.
Bullet list of complications to check for at each study visit from the date of randomization upt to 12 months
List of complications in Case report file:
Avascular bleb Bleb fibrosis Choroidal effusion Corectopia Corneal edema Corneal erosion Cystoid macular edema Descemet folds Epiretinal membrane Fibrin IOL Foreign body sensation Hematic tyndall Hypotony > 1 month Hypotony Maculopathy Iris incarceration Iris synechiae Lamellar macular hole Posterior capsule opacity Postoperative shunt closure Postoperative uveitis Seidel (early) Shallow anterior chamber Subconjunctival hemorrhage Tenon Cist Transient hypotony VA declined > 2 Snellen lines Vitreous in anterior chamber
Measured: Up to 12 months
Number of hypotensive medications needed
Number of drugs prescribed by investigator to keep IOP under target from the date of randomization up to 12 months
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study startFeb 2012
- Primary completionJun 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Catala de Retina
- Sponsor type
- University, hospital or other
- Collaborators
- Gregorio Marañón Hospital, Clinica Universidad de Navarra, Universidad de Navarra, Hospital Vall d'Hebron, Hospital Universitario Ramon y Cajal, Hospital San Eloy, Hospital del Mar
- Responsible party
- Sponsor
- Investigators
- Alfonso Antón, MD, PhD, Principal investigator, Institut Catala de Retina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201354
- Sponsor's protocol ID
- ICR-01 Ex-PRESS
- Status last verified
- Jun 2017
- First submitted
- 21 Dec 2011
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the ExPRESS Implant Versus Deep Sclerectomy in Combined Surgery: Prospective, Multi-center, Comparative Study
- ClinicalTrials.gov ID
- NCT03201354
- Acronym / sponsor ID
- ICR-01 Ex-PRESS
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Keywords
- Glaucoma, Ocular hypertension, Filtration surgery, Trabeculectomy with Ex-PRESS, Non penetrating deep sclerectomy, Phacoemulsification, Combined surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Institut Catala de RetinaUniversity, hospital or other
- Collaborators
- Gregorio Marañón Hospital, Clinica Universidad de Navarra, Universidad de Navarra, Hospital Vall d'Hebron, Hospital Universitario Ramon y Cajal, Hospital San Eloy, Hospital del Mar
- Study start
- Feb 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 28 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Ex-PRESS Glaucoma Filtration Device is a small, non-valved implant that was designed to lower intraocular pressure (IOP) by shunting aqueous humor from the anterior chamber into the subconjunctival space. The implant was developed in response to the need for more straightforward, standardized and safe surgical technique than standard filtration surgery. No iridectomy and no sclerectomy is needed if an Ex-PRESS device is implanted under a partial-thickness scleral flap. This may reduce surgical time and complications when compared to a standard trabeculectomy.
In some studies it has been found to be safe and effective with few complications, even in high-risk patients. No previous studies have compared filtration surgery with Ex-Press implant to deep sclerectomy.
Detailed description
Hypothesis:
In combined procedure (cataract and filtering surgery), the effect of Ex-PRESS device has similar efficacy reducing intraocular pressure than non penetrant deep sclerectomy and with good level of safety.
Objective:
To evaluate and compare the efficacy and safety at 12 months of the filtering surgery with the Ex-PRESS device with that of deep sclerectomy.
Methods:
Design: Multi-center, prospective, simple-blind, randomized study.
Primary variable:
- Intraocular pressure.
Secondary variables:
- Success rate at IOP <18
- Frequency and type of complications
- Number of hypotensive drugs needed.
Sample size calculation: Accepting an alfa risk of 0.05 and a beta risk of 0.20 in a two-sided Student's T-test, 50 subjects are necessary in first group and 50 in the second to recognize as statistically significant a difference greater than or equal to 10% in IOP, with a common standard deviation of 17%. A drop-out rate of 8% has been anticipated. If no drop-out rate is considered, the number of needed subjects is 92 (46 per group).
If the drop out rate is more than 8%:
- If the recruitment period is open, another subjects will be included.
- If the recruitment period os close, the inclusion of another subject will be evaluated to maintain the statistic power of the study.
Method
-Single blinded. Each patient will be assigned to one of the two arms (Ex-PRESS or Deep sclerectomy) the same day of surgery. The surgeon will be informed of the randomization result just before surgery by the study coordinator.
Pre-operative examinations:
History summarizing previous surgical procedures, intraocular pressure while on treatment, target pressure at the discretion of the surgeon, visual field (SITA standard 24-2), gonioscopy, and a detailed description of the optic disc / nerve fiber layer by a glaucoma specialist was performed in all subjects included.
Post-operative examinations
Visits were undertaken at 1 day, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months, and 12 months.
Tests:
- visual fields (month 12)
- gonioscopy (month 12)
- intraocular pressure (all visits)
- optic disc examination (all visits, under dilation at 3 and 12 month)
- Pachymetry (preop exam)
- endothelial cell count (months 3 and 12)
- Bleb morphology (month 1 and 12)
- methodic registration of complications (all visits)
A specific CRF was designed with all variables and data required for the study which included a long list of individual potential complications
Pre-operative treatment. Prostaglandin analogues will be discontinued one week before surgery, but the rest of hypotensive drugs will be maintained until the day of surgery
Surgery. Each patient was assigned to one of the two arms (Ex-PRESS or Deep sclerectomy) the same day of surgery. The surgeon wil be informed of the randomization result just before surgery by the study coordinator.
The surgical technique is as follows: retro/peribulbar o subtenon's anesthesia, superior rectus or corneal traction suture, phacoemulsification through 2.1 to 2.8 mm incision with IOL implantation, a fornix-based conjunctival flap, sufficient but not excessive cauterization, application MMC 0,2 mg/ml for 2 minutes under the conjunctiva, then MMC was washed out with 50 ml of saline solution, then and according to the randomization result a scleral flap (5x5 mm in the NPDS, 4x4 mm in the Ex-Press group) is dissected.
Group 1. Then the Ex-PRESS device was placed according to the manufacturer's instructions and its position in the anterior chamber was verified by the surgeon.
Group 2. Deep sclerectomy (NPDS) was performed by dissecting a Deep scleral flap (4x4 mm) and peeling the trabeculo-descement membrane. A Esnoper (AJL, Vitoria, Spain) device was positioned under the external scleral flap and fixated with a 10/0 nylon suture.
Suture Nylon 10/00 suture was used to place four or five stitches in the Ex-Press group and 2 stitches in the NPDS group. Then a hermetic conjunctival suture was performed at the limbus with 10/0 nylon.
Post-operative treatment. All patients instilled Moxifloxacin Antibiotic every 6 hours for 1 week, Dexamethasone (every 2 hours for 1 month, every 4-6 hours on the second month and gradually tapered on the third month according to surgeon's instructions). Atropine was also used at the discretion of the surgeon when clinical finds recommended its use.
Suture lysis or gonio-punture were indicated and performed at the discretion of the surgeon, and they were always registered in the CRF.
Subconjunctival injections of anti-fibrotic agents and/or bleb needling were allowed and performed at the discretion of the surgeon.
DATA ANALYSIS Variables will be checked for normality using the Shapiro-Wilk test. The mean and standard deviation is going to be used to describe normally distributed variables which will be compared between independent groups using the Student t test. Variables that are found to be not normally distributed will be described by median and quartiles, and their comparison between independent groups wil be performed using the Mann-Whitney U test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Filtration surgery with Express | Active comparator | Procedure: Filtration surgery with Ex-PRESS, Procedure: Cataract extractionFiltration surgery with Ex-PRESS + cataract extraction (Cataract surgery and IOL implantation) |
| Non penetrating surgery | Active comparator | Procedure: Non penetrating deep sclerectomy, Procedure: Cataract extraction- Filtration surgery with Non penetrating deep sclerectomy + cataract extraction (Cataract surgery and IOL implantation) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Diagnosis of open-angle glaucoma. Points a, b and c will be required:
- Disease poorly controlled with medical treatment and/or laser at the discretion of the ophthalmologist (progression, higher than targeted pressure, poor compliance…)
- Cataract with visual acuity between 0,1 (20/200) and 0.8 (20/25)
Key exclusion criteria (3 listed)
- Inflammatory, neovasular, closed-angle, normotensive glaucoma secondary to corticoids, or any type of glaucoma with advanced degree of functional lesion (Mean Defect < -20 dB)
- Previous glaucoma surgery
- Previous intraocular ocular surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Filtration surgery with Ex-PRESSFiltration surgery with Ex-PRESS | Procedure or surgery | Filtration surgery with Express |
| Non penetrating deep sclerectomyNon penetrating deep sclerectomy | Procedure or surgery | Non penetrating surgery |
| Cataract extractionCataract surgery and IOL implantation | Procedure or surgery | Filtration surgery with Express, Non penetrating surgery |
Primary outcome
Intraocular pressure
Time frame: Up to 12 months
mmHg
3 secondary outcomes
Success rate at IOP <18
Time frame: Up to 12 months
Number of participants with adverse events assesed by questionare in case report file.
Time frame: Up to 12 months
Number of hypotensive medications needed
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfonso Antón, MD, PhD principal investigator
Institut Catala de Retina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Filtration surgery with Ex-PRESS, Non penetrating deep sclerectomy and Cataract extraction in people with Open Angle Glaucoma and Ocular Hypertension, run by Institut Catala de Retina at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2017.