Micropulsed Laser Trabeculoplasty Using Different Parameters
NCT ID: NCT04900142
Last Updated: 2021-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2020-03-20
2022-06-20
Brief Summary
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The main outcome is to evaluate the IOP (IntraOcular Pressure) lowering effects of both treatments and the safety on the corneal endothelium.
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Detailed Description
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Exclusion criteria are: secondary glaucoma, previous glaucoma surgery (not including cataract surgery as a glaucoma surgery), uncooperative patients, corneal endothelial diseases (such as Fuchs dystrophy or cornea guttata) and severely decompensated glaucoma.
Both eyes of the patient are treated: each eye is allocated in a group using the closed envelopes method. Both the patient and the surgeon who performs the post laser examinations are not aware of the group allocation.
The exams required before the trabeculoplasty are: best corrected visual acuity, IOP measurement, specular microscopy with corneal central thickness.
The IOP is measured an hour after MLT (micropulsed laser trabeculoplasty), then on day one, at one month, at three months and six months. Best corrected visual acuity and specular microscopy are repeated at three months.
Expected outcomes: to compare the IOP lowering effects between group one and two and to assess the safety of the procedure on the corneal endothelium.
Secondary outcomes: decrease the number of glaucoma medications applied by the patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1500 mW
1500 mW of Power
Micropulsed laser trabeculoplasty
Trabeculoplasty
1000 mW
Standard treatment, 1000 mW
Micropulsed laser trabeculoplasty
Trabeculoplasty
Interventions
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Micropulsed laser trabeculoplasty
Trabeculoplasty
Eligibility Criteria
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Inclusion Criteria
* Pigmentary glaucoma
* Pseudoexfoliative glaucoma
Exclusion Criteria
* Previous glaucoma surgery
* Severely decompensated glaucoma
* Corneal endothelial disease
ALL
No
Sponsors
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University of Modena and Reggio Emilia
OTHER
Responsible Party
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Gian Maria Cavallini
Associate Professor
Principal Investigators
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Mastropasqua Rodolfo, MD, Professor
Role: STUDY_DIRECTOR
Policlinico di Modena
Locations
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Policlinico di Modena
Modena, , Italy
Policlinico di Modena
Modena, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1152/2019/DISP/AOUMO
Identifier Type: -
Identifier Source: org_study_id
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