Glaucoma EyeNCT04648943
The Effect of Trabeculectomy & Ex-PRESS Glaucoma Drainage Implant on the Corneal Biomechanical Properties
A study testing Ex-Press mini shunt insertion and Trabeculectomy in people with Glaucoma Eye, run by Democritus University of Thrace.
Trial summary
This study aims to look into the change of the corneal biomechanical properties in patients undergoing insertion of the Ex-PRESS mini shunt or trabeculectomy for medically uncontrolled glaucoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma Eye
- What is being tested?
- Ex-Press mini shunt insertion and Trabeculectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2013to 30 Nov 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
- Age > 18
- Average Intraocular pressure > 24 mmHg on at least 2 occasions 1 month before surgery
- Congenital glaucoma
Who cannot join
- Previous ocular trauma
- Previous ocular surgery other than phacoemulsification
- Previous disease of the ocular surface
About this study
Official title: The Effect of Antiglaucoma Procedures (Trabeculectomy vs. Ex-PRESS Glaucoma Drainage Implant) on the Corneal Biomechanical Properties
This study aims to look into the change of the corneal biomechanical properties in patients undergoing insertion of the Ex-PRESS mini shunt or trabeculectomy for medically uncontrolled glaucoma
Read the detailed description
The patients in the study were divided into two groups. In group 1 the patients had the Ex-PRESS mini shunt inserted in the operated eye and in group 2 the patients underwent standard trabeculectomy.
The corneal biomechanical properties were measured with the Ocular Response Analyzer before surgery and at 1, 6 and 12 months after surgery. The corneal biomechanical properties measured were the Corneal Hysteresis (CH) and the Corneal Resistance Factor (CRF).
The change of the CH and CRF was compared in each group before and after surgery (at the aforementioned predetermined time points) and between the two groups.
The intraocular pressure was also measured with the Goldmann applanation tonometer at the same time points and the change was compared before and after surgery in each group and between the two groups.
- Conditions
- Glaucoma Eye
- Being tested
- Ex-Press mini shunt insertion, Trabeculectomy
- Keywords
- glaucoma, trabeculectomy, Ex-PRESS glaucoma drainage implant, corneal hysteresis, corneal resistance factor
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ex-Press mini shunt insertionProcedure or surgery
TrabeculectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing Ex-Press mini shunt insertion | Active comparator | Patients in this arm had the Ex-Press mini shunt inserted in the operated eye in order to reduce the Intraocular Pressure. The corneal biomechanical properties were measured before and at 1, 6 and 12 months after surgery with the Ocular Response Analyzer Receives: Procedure: Ex-Press mini shunt insertion |
| Patients undergoing trabeculectomy | Active comparator | Patients in this arm had standard trabeculectomy in the operated eye in order to reduce the Intraocular Pressure. The corneal biomechanical properties were measured before and at 1, 6 and 12 months after surgery with the Ocular Response Analyzer Receives: Procedure: Trabeculectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of corneal biomechanical properties
Two corneal biomechanical properties were measured with the use of the Ocular Response Analyzer (ORA): the Corneal Resistance Factor (CRF) and the Corneal Hysteresis (CH).
These two indicators were measured before surgery and at 1, 6 and 12 months after surgery
Measured: 12 months
Secondary outcomes (1)
Change of Intraocular Pressure
The Intraocular Pressure was measured with the Goldmann applanation tonometer before surgery and at 1, 6 and 12 months after surgery
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start1 Jul 2013
- Primary completion31 May 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma EyeStudies 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
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Democritus University of Thrace
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Labiris, Democritus University of Thrace
- Investigators
- Georgios Labiris, MD, PhD, Study chair, Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648943
- Sponsor's protocol ID
- ES8/Th11/10-10-2013
- Status last verified
- Nov 2020
- First submitted
- 21 Nov 2020
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Antiglaucoma Procedures (Trabeculectomy vs. Ex-PRESS Glaucoma Drainage Implant) on the Corneal Biomechanical Properties
- ClinicalTrials.gov ID
- NCT04648943
- Acronym / sponsor ID
- ES8/Th11/10-10-2013
- Conditions
- Glaucoma Eye
- Keywords
- glaucoma, trabeculectomy, Ex-PRESS glaucoma drainage implant, corneal hysteresis, corneal resistance factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- 1 Jul 2013 (actual)
- Primary completion
- 31 May 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 2 Dec 2020 (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.
This study aims to look into the change of the corneal biomechanical properties in patients undergoing insertion of the Ex-PRESS mini shunt or trabeculectomy for medically uncontrolled glaucoma
Detailed description
The patients in the study were divided into two groups. In group 1 the patients had the Ex-PRESS mini shunt inserted in the operated eye and in group 2 the patients underwent standard trabeculectomy.
The corneal biomechanical properties were measured with the Ocular Response Analyzer before surgery and at 1, 6 and 12 months after surgery. The corneal biomechanical properties measured were the Corneal Hysteresis (CH) and the Corneal Resistance Factor (CRF).
The change of the CH and CRF was compared in each group before and after surgery (at the aforementioned predetermined time points) and between the two groups.
The intraocular pressure was also measured with the Goldmann applanation tonometer at the same time points and the change was compared before and after surgery in each group and between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing Ex-Press mini shunt insertion | Active comparator | Procedure: Ex-Press mini shunt insertionPatients in this arm had the Ex-Press mini shunt inserted in the operated eye in order to reduce the Intraocular Pressure. The corneal biomechanical properties were measured before and at 1, 6 and 12 months after surgery with the Ocular Response Analyzer |
| Patients undergoing trabeculectomy | Active comparator | Procedure: TrabeculectomyPatients in this arm had standard trabeculectomy in the operated eye in order to reduce the Intraocular Pressure. The corneal biomechanical properties were measured before and at 1, 6 and 12 months after surgery with the Ocular Response Analyzer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18
- Average Intraocular pressure > 24 mmHg on at least 2 occasions 1 month before surgery
- Congenital glaucoma
Key exclusion criteria (3 listed)
- Previous ocular trauma
- Previous ocular surgery other than phacoemulsification
- Previous disease of the ocular surface
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 |
|---|---|---|
| Ex-Press mini shunt insertion | Procedure or surgery | Patients undergoing Ex-Press mini shunt insertion |
| Trabeculectomy | Procedure or surgery | Patients undergoing trabeculectomy |
Primary outcome
Change of corneal biomechanical properties
Time frame: 12 months
Two corneal biomechanical properties were measured with the use of the Ocular Response Analyzer (ORA): the Corneal Resistance Factor (CRF) and the Corneal Hysteresis (CH). These two indicators were measured before surgery and at 1, 6 and 12 months after surgery
1 secondary outcome
Change of Intraocular Pressure
Time frame: 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 2 Dec 2020.
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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.
Georgios Labiris, MD, PhD study chair
Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece
Questions about this trial
What is this clinical trial studying?
A study testing Ex-Press mini shunt insertion and Trabeculectomy in people with Glaucoma Eye, run by Democritus University of Thrace.
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 3 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 2 Dec 2020. 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?
Change of corneal biomechanical properties (time frame: 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 2 Dec 2020.