Glaucoma, Open-AngleNCT03800589
Assessment of Effectiveness Ex-Press Surgery Modification
A study testing phacoemulsification with implantation of the Ex-Press and deep sclerectomy, phacoemulsification, ExPress implantation in people with Glaucoma, Open-Angle and Glaucoma Secondary, run by Military Institute od Medicine National Research Institute.
Trial summary
The purpose of the study is to compare the effectiveness and safety profile of ExPress implantation versus partial deep sclerectomy combined with ExPress implantation with simultaneously phacoemulsification. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Open-Angle, Glaucoma Secondary, Glaucoma, Primary Open Angle
- What is being tested?
- phacoemulsification with implantation of the Ex-Press and deep sclerectomy, phacoemulsification, ExPress implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2010to 1 Dec 2017
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- co-existing glaucoma and cataract (NC1, NC2) classified by means of the LOCS III scale
- patients with primary open-angle glaucoma (POAG), pseudoexfoliative glaucoma (PGX) and normal tension glaucoma (NTG), in which a satisfactory IOP level was not achieved despite maximum tolerable hypotensive treatment, both topical and systemic,
- documented progression of loss of field of vision,
- significant daily IOP fluctuations,
- no cooperation from patient with regard to application of anti-glaucoma treatment,
- allergy to topical medication
- written consent to involvement and participation in the study for a period of at least 24 months
Who cannot join
- no consent to participation in the study
- prior surgical and laser procedures in the area of the eye
- narrow- or closed-angle glaucoma
- post-inflammatory or post-traumatic secondary glaucoma
- chronic illness of the cornea or optic nerve
- advanced macular degeneration
Show all 9Show fewer
- active inflammatory process
- pregnancy
- systemic steroid therapy
About this study
Official title: Comparison of ExPress Implantation Versus Partial Deep Sclerectomy Combined With ExPress Implantation With Simultaneously Phacoemulsification
The purpose of the study is to compare the effectiveness and safety profile of ExPress implantation versus partial deep sclerectomy combined with ExPress implantation with simultaneously phacoemulsification.
Read the detailed description
Mermoud et all (1) proposed a modification of the classical surgical technique: combined deep sclerectomy (DS) with ExPress device implantation. The goal of this modification was to enhance hypotensive effect of well known procedure, and also to simplify non-penetrating surgery, which is a procedure with a long learning curve. Mermoud's idea provides the possibility of avoiding complications related to dissection of the filtering bleb and gives hope for achieve of better results in comparison to the classical procedure. Thanks to this, the surgical procedure could be performed earlier, even in the case of glaucoma with low intraocular pressure (IOP), where vascular factors are largely responsible for the progression of neuropathy. To demonstrate the potential of both types of procedures with the application of the ExPress implant, the authors decided to conduct a prospective, randomized study with a 2-year observation period concerning the efficacy, safety and stability of effects achieved.
- Being tested
- phacoemulsification with implantation of the Ex-Press, deep sclerectomy, phacoemulsification, ExPress implantation
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phacoemulsification with implantation of the Ex-PressProcedure or surgery
The conjunctiva is dissected with the base in the limbus. A square scleral flap is dissected with the based in the limbus. Phacoemulsification is performed through a corneal incision 2.75 mm from the temple using the phaco-chop technique. Mini seton was implanted at 12 o'clock according to the standard technique.
deep sclerectomy, phacoemulsification, ExPress implantationProcedure or surgery
The conjunctiva is dissected with the base in the limbus. Superficial flap is dissected with the based in the limbus. Phacoemulsification is performed through a corneal incision 2.75 mm from the temple using the phaco-chop technique. Deep scleral is dissected just below the trabeculo-Descemet membrane. The seton is implanted in the anterior chamber at the height of Schlemm's Canal.
| Study group | Role | What they receive |
|---|---|---|
| phaco and Ex-Press | Active comparator | patients with co-existing cataract and glaucoma, qualified to the combined glaucoma surgery according to the protocol which were randomized to phacoemulsification with implantation of the Ex-Press Receives: Procedure: phacoemulsification with implantation of the Ex-Press |
| deep sclerectomy, phaco and Ex-press | Active comparator | patients with co-existing cataract and glaucoma, qualified to the combined glaucoma surgery according to the protocol which were randomized to deep sclerectomy, phacoemulsification, ExPress implantation Receives: Procedure: deep sclerectomy, phacoemulsification, ExPress implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP
the change in level of intraocular pressure
Measured: baseline, and 24th month after surgery
CDVA
the change in corrected distance visual acuity
Measured: baseline, and 24th month after surgery
number of drugs
the change in number of antiglaucoma medications
Measured: baseline, and 24th month after surgery
Secondary outcomes (1)
number of complications
rate of complications
Measured: in a day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start1 Dec 2010
- Primary completion1 Dec 2016
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glaucoma, Open-AngleStudies 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
- Model description
- Prospective, randomized control study with 24-month follow-up.
- Masking
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Military Institute od Medicine National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marek Rękas, Prof, Principal investigator, Military Institute of Medicine in Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03800589
- Sponsor's protocol ID
- 15/WIM/2010
- Status last verified
- Jan 2019
- First submitted
- 8 Jan 2019
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available
Publications
Bissig A, Feusier M, Mermoud A, Roy S. Deep sclerectomy with the Ex-PRESS X-200 implant for the surgical treatment of glaucoma. Int Ophthalmol. 2010 Dec;30(6):661-8. doi: 10.1007/s10792-010-9382-z. Epub 2010 Jun 16.
PubMed 20552258
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of ExPress Implantation Versus Partial Deep Sclerectomy Combined With ExPress Implantation With Simultaneously Phacoemulsification
- ClinicalTrials.gov ID
- NCT03800589
- Acronym / sponsor ID
- 15/WIM/2010
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Military Institute od Medicine National Research InstituteUniversity, hospital or other
- Study start
- 1 Dec 2010 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 11 Jan 2019 (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 purpose of the study is to compare the effectiveness and safety profile of ExPress implantation versus partial deep sclerectomy combined with ExPress implantation with simultaneously phacoemulsification.
Detailed description
Mermoud et all (1) proposed a modification of the classical surgical technique: combined deep sclerectomy (DS) with ExPress device implantation. The goal of this modification was to enhance hypotensive effect of well known procedure, and also to simplify non-penetrating surgery, which is a procedure with a long learning curve. Mermoud's idea provides the possibility of avoiding complications related to dissection of the filtering bleb and gives hope for achieve of better results in comparison to the classical procedure. Thanks to this, the surgical procedure could be performed earlier, even in the case of glaucoma with low intraocular pressure (IOP), where vascular factors are largely responsible for the progression of neuropathy. To demonstrate the potential of both types of procedures with the application of the ExPress implant, the authors decided to conduct a prospective, randomized study with a 2-year observation period concerning the efficacy, safety and stability of effects achieved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized control study with 24-month follow-up.
| Arm | Type | Receives |
|---|---|---|
| phaco and Ex-Press | Active comparator | Procedure: phacoemulsification with implantation of the Ex-Presspatients with co-existing cataract and glaucoma, qualified to the combined glaucoma surgery according to the protocol which were randomized to phacoemulsification with implantation of the Ex-Press |
| deep sclerectomy, phaco and Ex-press | Active comparator | Procedure: deep sclerectomy, phacoemulsification, ExPress implantationpatients with co-existing cataract and glaucoma, qualified to the combined glaucoma surgery according to the protocol which were randomized to deep sclerectomy, phacoemulsification, ExPress implantation |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- co-existing glaucoma and cataract (NC1, NC2) classified by means of the LOCS III scale
- patients with primary open-angle glaucoma (POAG), pseudoexfoliative glaucoma (PGX) and normal tension glaucoma (NTG), in which a satisfactory IOP level was not achieved despite maximum tolerable hypotensive treatment, both topical and systemic,
- documented progression of loss of field of vision,
- significant daily IOP fluctuations,
- no cooperation from patient with regard to application of anti-glaucoma treatment,
Key exclusion criteria (9 listed)
- no consent to participation in the study
- prior surgical and laser procedures in the area of the eye
- narrow- or closed-angle glaucoma
- post-inflammatory or post-traumatic secondary glaucoma
- chronic illness of the cornea or optic nerve
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 |
|---|---|---|
| phacoemulsification with implantation of the Ex-PressThe conjunctiva is dissected with the base in the limbus. A square scleral flap is dissected with the based in the limbus. Phacoemulsification is performed through a corneal incision 2.75 mm from the temple using the phaco-chop technique. Mini seton was implanted at 12 o'clock according to the standard technique. | Procedure or surgery | phaco and Ex-Press |
| deep sclerectomy, phacoemulsification, ExPress implantationThe conjunctiva is dissected with the base in the limbus. Superficial flap is dissected with the based in the limbus. Phacoemulsification is performed through a corneal incision 2.75 mm from the temple using the phaco-chop technique. Deep scleral is dissected just below the trabeculo-Descemet membrane. The seton is implanted in the anterior chamber at the height of Schlemm's Canal. | Procedure or surgery | deep sclerectomy, phaco and Ex-press |
Primary outcome
IOP
Time frame: baseline, and 24th month after surgery
the change in level of intraocular pressure
CDVA
Time frame: baseline, and 24th month after surgery
the change in corrected distance visual acuity
number of drugs
Time frame: baseline, and 24th month after surgery
the change in number of antiglaucoma medications
1 secondary outcome
number of complications
Time frame: in a day of surgery
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 16 Jan 2019.
- Results publication: PubMed 20552258Bissig A, Feusier M, Mermoud A, Roy S. Deep sclerectomy with the Ex-PRESS X-200 implant for the surgical treatment of glaucoma. Int Ophthalmol. 2010 Dec;30(6):661-8. doi: 10.1007/s10792-010-9382-z. Epub 2010 Jun 16.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available
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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.
Marek Rękas, Prof principal investigator
Military Institute of Medicine in Warsaw
Questions about this trial
What is this clinical trial studying?
A study testing phacoemulsification with implantation of the Ex-Press and deep sclerectomy, phacoemulsification, ExPress implantation in people with Glaucoma, Open-Angle and Glaucoma Secondary, run by Military Institute od Medicine National Research Institute.
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 7 inclusion and 9 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 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
IOP (time frame: baseline, and 24th month after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03800589, which also lists 1 linked publication.
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 16 Jan 2019.