Pseudoexfoliation GlaucomaNCT03483402
Micropulse Laser Trabeculoplasty as Adjunctive Treatment in Patients With Pseudoexfoliation Glaucoma
A study testing Micropulse laser trabeculoplasty in people with Pseudoexfoliation Glaucoma and Primary Open-angle Glaucoma, run by University Hospital of Patras.
Trial summary
This study aims to evaluate the effect of a single session of micropulse laser trabeculoplasty (MLT) on cornea in eyes with primary open glaucoma (POAG) and pseudoexfoliation glaucoma (PEXG). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pseudoexfoliation Glaucoma, Primary Open-angle Glaucoma
- What is being tested?
- Micropulse laser trabeculoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to 2 Apr 2018
- 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
- Patients with POAG or PEXG under treatment with glaucoma agents requiring additional reduction of IOP, age older than 18 years, patients willing to provide informed consent to participate in the study and to adhere to the follow-up schedule.
Who cannot join
- pre-existing corneal pathology or scar, history of any previous ocular surgery or any planned ocular surgery during the study, history of prior laser trabeculoplasty, end-stage glaucoma with advanced visual field defect, monocular patients, history of trauma, and concurrent systemic or topical steroid use
- patients unable to present for follow up
About this study
Official title: Study of the Efficacy of a Single Session Micropulse Laser Trabeculoplasty as an Adjunctive Measure in Decreasing Intraocular Pressure in Patients Suffering From Pseudoexfoliation Glaucoma
This study aims to evaluate the effect of a single session of micropulse laser trabeculoplasty (MLT) on cornea in eyes with primary open glaucoma (POAG) and pseudoexfoliation glaucoma (PEXG).
Read the detailed description
Patients with PEXG under prostaglandine analogue monotherapy with inadequate IOP control are treated with 360-degrees 532nm MLT.
Patients are evaluated at 1 day, 1 month, 3 months, 6 months and 12 months post-MLT. After trabeculoplasty patients are maintained in treatment with the same drug regimen as pre-MLT.
- Being tested
- Micropulse laser trabeculoplasty
- Keywords
- Pseudoexfoliation Glaucoma, Primary Open-angle Glaucoma, Micropulse Laser Trabeculoplasty, Intraocular Pressure
- Medical subject headings
- Exfoliation Syndrome, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micropulse laser trabeculoplastyProcedure or surgery
Also called MLT Iridex IQ 532 laser system
Micropulse laser trabeculoplasty is performed using the Iridex IQ 532 laser system (Iridex Corporation, 1212 Terra Bella Avenue, Mountain View, CA, USA) and 532 nm (green) wavelength MLT is applied with confluent applications to pigmented trabecular meshwork over 360 degrees using a 300 µm spot size, 300 ms duration, 1000 mW power and 15% duty cycle.
| Study group | Role | What they receive |
|---|---|---|
| PEXG treated with MLT | Experimental | Patients with pseudoexfoliation glaucoma (PEXG) under prostaglandine analogue monotherapy with inadequate IOP control treated with 360-degrees 532nm micropulse laser trabeculoplasty (MLT) Receives: Procedure: Micropulse laser trabeculoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure
The change in IOP at 12 months versus baseline and the percentage of patients with ≥20% reduction in IOP.
Measured: 12 months
Secondary outcomes (1)
Intraocular Pressure
Change in IOP and the percentage of ≥20% IOP reduction at 1, 3 and 6 months after MLT
Measured: 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study startDec 2016
- Primary completion30 Mar 2018
- Study completion2 Apr 2018
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 Pseudoexfoliation 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single-center, one-arm, prospective clinical trial.
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Constantinos D. Georgakopoulos, MD, PhD, University Hospital of Patras
- Investigators
- Constantine D Georgakopoulos, MD, PhD, Principal investigator, University of Patras, Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483402
- Sponsor's protocol ID
- 58/15.02.2018/5103
- Status last verified
- Apr 2018
- First submitted
- 23 Mar 2018
- Last updated
- 4 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Makri OE, Pallikari A, Pagoulatos D, Kagkelaris K, Kostopoulou EV, Georgakopoulos CD. Micropulse laser trabeculoplasty on pseuodexfoliation glaucoma patients under topical prostaglandin analogue monotherapy: 1-year results. Graefes Arch Clin Exp Ophthalmol. 2019 Feb;257(2):349-355. doi: 10.1007/s00417-018-4195-2. Epub 2018 Nov 28.
PubMed 30488265
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Efficacy of a Single Session Micropulse Laser Trabeculoplasty as an Adjunctive Measure in Decreasing Intraocular Pressure in Patients Suffering From Pseudoexfoliation Glaucoma
- ClinicalTrials.gov ID
- NCT03483402
- Acronym / sponsor ID
- 58/15.02.2018/5103
- Keywords
- Pseudoexfoliation Glaucoma, Primary Open-angle Glaucoma, Micropulse Laser Trabeculoplasty, Intraocular Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Hospital of PatrasUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 2 Apr 2018 (actual)
- First posted
- 30 Mar 2018 (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 evaluate the effect of a single session of micropulse laser trabeculoplasty (MLT) on cornea in eyes with primary open glaucoma (POAG) and pseudoexfoliation glaucoma (PEXG).
Detailed description
Patients with PEXG under prostaglandine analogue monotherapy with inadequate IOP control are treated with 360-degrees 532nm MLT.
Patients are evaluated at 1 day, 1 month, 3 months, 6 months and 12 months post-MLT. After trabeculoplasty patients are maintained in treatment with the same drug regimen as pre-MLT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-center, one-arm, prospective clinical trial.
| Arm | Type | Receives |
|---|---|---|
| PEXG treated with MLT | Experimental | Procedure: Micropulse laser trabeculoplastyPatients with pseudoexfoliation glaucoma (PEXG) under prostaglandine analogue monotherapy with inadequate IOP control treated with 360-degrees 532nm micropulse laser trabeculoplasty (MLT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with POAG or PEXG under treatment with glaucoma agents requiring additional reduction of IOP, age older than 18 years, patients willing to provide informed consent to participate in the study and to adhere to the follow-up schedule.
Key exclusion criteria (2 listed)
- pre-existing corneal pathology or scar, history of any previous ocular surgery or any planned ocular surgery during the study, history of prior laser trabeculoplasty, end-stage glaucoma with advanced visual field defect, monocular patients, history of trauma, and concurrent systemic or topical steroid use
- patients unable to present for follow up
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 |
|---|---|---|
| Micropulse laser trabeculoplastyAlso: MLT Iridex IQ 532 laser systemMicropulse laser trabeculoplasty is performed using the Iridex IQ 532 laser system (Iridex Corporation, 1212 Terra Bella Avenue, Mountain View, CA, USA) and 532 nm (green) wavelength MLT is applied with confluent applications to pigmented trabecular meshwork over 360 degrees using a 300 µm spot size, 300 ms duration, 1000 mW power and 15% duty cycle. | Procedure or surgery | PEXG treated with MLT |
Primary outcome
Intraocular Pressure
Time frame: 12 months
The change in IOP at 12 months versus baseline and the percentage of patients with ≥20% reduction in IOP.
1 secondary outcome
Intraocular Pressure
Time frame: 1, 3 and 6 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 4 Apr 2018.
- Derived from this study: PubMed 30488265Makri OE, Pallikari A, Pagoulatos D, Kagkelaris K, Kostopoulou EV, Georgakopoulos CD. Micropulse laser trabeculoplasty on pseuodexfoliation glaucoma patients under topical prostaglandin analogue monotherapy: 1-year results. Graefes Arch Clin Exp Ophthalmol. 2019 Feb;257(2):349-355. doi: 10.1007/s00417-018-4195-2. Epub 2018 Nov 28.
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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.
Constantine D Georgakopoulos, MD, PhD principal investigator
University of Patras, Medical School
Questions about this trial
What is this clinical trial studying?
A study testing Micropulse laser trabeculoplasty in people with Pseudoexfoliation Glaucoma and Primary Open-angle Glaucoma, run by University Hospital of Patras.
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 1 inclusion and 2 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 4 Apr 2018. 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?
Intraocular Pressure (time frame: 12 months). 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 NCT03483402, 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 4 Apr 2018.