Ignite Creation Date:
2024-05-06 @ 4:11 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04900142
Status:
UNKNOWN
Last Update Posted:
2021-05-25
First Post:
2020-12-19
Brief Title:
Micropulsed Laser Trabeculoplasty Using Different Parameters
Sponsor:
University of Modena and Reggio Emilia
Organization:
University of Modena and Reggio Emilia
Study Overview
Official Title:
Micropulsed Laser Trabeculoplasty a Randomized Double Blinded Clinical Trial Using Different Parameters
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized double blinded clinical trial compares two different parameters setting of micropulsed laser trabeculoplasty for open angle glaucoma Group one is treated with 1500 mW of Power Group two with 1000 mW The other settings 300 micron of diameter 300 ms of duration 15 duty cycle are the same for both groups and the laser is applied for 360
The main outcome is to evaluate the IOP IntraOcular Pressure lowering effects of both treatments and the safety on the corneal endothelium
The main outcome is to evaluate the IOP IntraOcular Pressure lowering effects of both treatments and the safety on the corneal endothelium
Detailed Description:
This study is a randomized double blinded clinical trial Eligibility criteria are primary open angle glaucoma pigmentary glaucoma and pseudoexfoliation glaucoma
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None