To lower the intraocular pressure in patients with refractary glaucoma
Design
Open label, non randomized, non comparative trial
Settings and conduct
Patients were selected consecutively, when fullfilling the trial criteria.afterwards the laser procedure was done by one surgen and the evaluation performed 12 months, after 1 week, 1 month, 3 months,6 monts and one year. At each visit, there were a series of ocular measurements and investigations done. All ocular determinations were saved and compared .
Participants/Inclusion and exclusion criteria
100 participants. Inclusion: IOP>21 mmHg, Age>18 years, signed informed consent. Exclusion : uveitis, history of ocular surgery in the last 3 months
Intervention groups
We apply the micropulse laser probe next to the limbus, and firmly slide the probe along the limbus. The laser is delivered in a micropulse way to the culiary body, increading the outflow way, lowering the IOP
Main outcome variables
IOP, medication number used before laser and after laser, patient s pain felt during the procedure, laser parameters
General information
Reason for update
Acronym
mTSCPC
IRCT registration information
IRCT registration number:IRCT20170325033136N2
Registration date:2018-05-18, 1397/02/28
Registration timing:prospective
Last update:2018-05-18, 1397/02/28
Update count:0
Registration date
2018-05-18, 1397/02/28
Registrant information
Name
Alexandra Preda
Name of organization / entity
Centrul Oftalmologic Prof Dr Munteanu
Country
Romania
Phone
0040745113511
Email address
alexandrapreda004@gmail.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2637-09-11, 2016/06/20
Expected recruitment end date
2639-03-11, 2017/12/20
Actual recruitment start date
2637-09-23, 2016/07/01
Actual recruitment end date
2639-03-06, 2017/12/15
Trial completion date
empty
Scientific title
Micropulse Transcleral Cyclophotocoagulation in the treatment of refractary glaucoma
Public title
Micropulse Transcleral Cyclophotocoagulation in the treatment of refractary glaucoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Intraocular pressure higher than 21 mmhg
Age > 18
Signed informed consent
Exclusion criteria:
Uveitis
Ocular surgery in the last 3 months, prior to study enrolment.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethics committee of the Ophtalmologica
Street address
B dul 3 August nr 2, Timisoara
City
Timisoara
Postal code
300668
Approval date
2637-09-06, 2016/06/15
Ethics committee reference number
1/01.06.2016
Health conditions studied
1
Description of health condition studied
Glaucoma, IOP
ICD-10 code
H40.9
ICD-10 code description
Unspecified glaucoma
Primary outcomes
1
Description
IOP decrease
Timepoint
1 week, 1 month, 3 months,6 months, 1 year
Method of measurement
Goldman aplanotonometry
Secondary outcomes
1
Description
Pain endurance
Timepoint
5 minutes after procedure
Method of measurement
VAS scale
2
Description
Number of eye drops after the procedure to control the IOP
Timepoint
1 month, 6 months, 1 year
Method of measurement
Asking patient
Intervention groups
1
Description
Intervention group: the intervention group is consisted of the nontreated eye. In each patient only one eye is treated with micropulse cyclophotocoagulation, the fellow eye represents control group. The treated group, consisted of the treated eye, underwent one session of micropulse transcleral cyclophotocoagulation(mTSCPC), after which standard eye drops were prescribed for 2 weeks. The treatment consisted of ciclopentolate, cortison (fluorometolona) and antibiotic (netilmicina). The glaucoma treatment was never interupted. The protocol included retrobulbar anesthesia with 1:1 mixture of 0.75% bupivacaine and 4% lidocaine and intravenous sedation (fentanyl/propofol), according to the patients’ pain tolerance. Laser settings were 2000 mW of 810 nm infrared diode laser set on micropulse delivery mode. The laser was delivered over 360° for 160-260 ms. The duty cycle was 31.3 %, which translated to 0.5 ms of “on time” and 1.1 ms of “off time”. The probe was applied in a sweeping motion, keeping firm pressure and moved from 10 o’clock to 2 o’clock for the superior quadrant, and from 4 o’clock to 8 o’clock for the inferior quadrant. The 3 and 9 o’clock areas and also any area of thinned sclera were avoided. Examinations were performed at 1 week, 1 month, 3 months, 6 months and 12 months after the procedure, and included anterior segment examination, anterior chamber reaction, and Goldmann applanation tonometry. All the ocular determinations were made between 9 and 11 am. We monitored intraocular pressure, best corrected visual acuity (BCVA), number and type of medications used. The device is called MicroPulse® P3 Glaucoma Device (MP3) IRIDEX. we want to comapre the intraocular pressure of the treated eye before the mTSCPC and how much it dropped, after one year. We also compare with the nontreated eye, and if the laser had any influence on the nontreated eye, considering the sympathetic connection between the eyes. The treated group consists 100 eyes, and the nontreated gropus, 100 eyes, the fellow eye.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Oftalmologica SRL
Full name of responsible person
Maria Alexandra Preda
Street address
B dul 3 August nr 2
City
Timisoara
Postal code
300668
Phone
+40 256 496 336
Email
Alexandrapreda004@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Alexandra Preda
Full name of responsible person
Alexandra Preda
Street address
B dul 3 August nr 2
City
Timisoara
Postal code
300668
Phone
+40 256 496 336
Email
superstarale@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alexandra Preda
Proportion provided by this source
10
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Centrul Oftalmologic Prof Dr Munteanu
Full name of responsible person
Alexandra Preda
Position
Ophtalmologic clinic
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Bulevardul 3 August, nr 2
City
Timisoara
Province
Timis
Postal code
300668
Phone
+40 745 113 511
Fax
+40 256 496 336
Email
alexandrapreda004@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Clinica Prof Dr Munteanu
Full name of responsible person
Alexandra Preda
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
B dul 3 August nr 2
City
Timisoara
Province
Timis
Postal code
300668
Phone
+40 745 113 511
Email
superstarale@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Clinica Prof Dr Munteanu
Full name of responsible person
Alexandra Preda
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
B dul 3 August nr 2
City
Timisoara
Province
Timis
Postal code
300668
Phone
+40 745 113 511
Email
superstarale@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
This are confidential and personal information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Inform consent
When the data will become available and for how long
12.2018
To whom data/document is available
Everybody interested in ophthalmology field
Under which criteria data/document could be used
Ciclophotocoagulation laser
From where data/document is obtainable
Our clinic
What processes are involved for a request to access data/document