Determining and comparing the effectiveness of drug treatment and Selective Laser Trabeculoplasty (SLT) in patients with POAG referred to AL Zahra Ophthalmology Hospital in 2023
Design
Clinical trial with randomized groups on 60 patients. Randomized blocks were used for randomization.
Settings and conduct
Al-Zahra Ophthalmology Hospital -2023
The eye pressure of both groups of patients will be evaluated by a doctor before the intervention, 1 month and 6 months after the intervention.
Participants/Inclusion and exclusion criteria
Criteria for entering the study:
1- Age more than 18 years
2- Diagnosis of POAG
Criteria for not entering the study:
1- Secondary glaucoma diagnosis
2- One eye patients
3-Having very high IOP (above 30 mm Hg)
4- Patients who have currently received maximum tolerated medical treatment (Maximum Tolerated Medical Treatment), but despite the treatment, their IOP is not controlled.
5- History of laser trabeculoplasty or retinal surgery
6- History of cataract surgery in the last 3 months
7-Active eye infection or inflammation
8- Narrow eye angle
9- Any eye disease that prevents accurate IOP measurement.
10- Pregnant or actively breastfeeding women
11- Any unstable medical condition that prevents compliance with the scientific and ethical bases of the study protocol.
Intervention groups
Entered patients will receive one of two treatment groups A or B. 30 patients will receive treatment (Selective Laser Trabeculoplasty 360 degrees in the angle of the eye) and 30 patients will also receive treatment (drug therapy based on the guidelines of the reference books initially with latanoprost drops or second choice with timolol drops).
Main outcome variables
Comparison of eye pressure of patients treated with laser and medicine together 1 month and 6 months after treatment
General information
Reason for update
Acronym
SLT
IRCT registration information
IRCT registration number:IRCT20230330057786N1
Registration date:2023-09-05, 1402/06/14
Registration timing:prospective
Last update:2023-09-05, 1402/06/14
Update count:0
Registration date
2023-09-05, 1402/06/14
Registrant information
Name
tahereh yavari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3323 3551
Email address
taherehyavari71@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of antiglaucoma drugs with Selective Laser Trabeculoplasty (SLT) in patients with primary open angle glaucoma
Public title
Comparison of the effect of laser and medicine in glaucoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 18 years
Diagnosis of POAG (POAG is an optic neuropathy with increased intraocular pressure in which the angle of the anterior chamber of the eye is open and no secondary disease or cause can be found to justify optic nerve damage or increased intraocular pressure).
Newly diagnosed patients and those who are currently receiving the standard first-line treatment, i.e. latanoprost eye drops, but their target IOP has not been achieved.
Exclusion criteria:
Secondary glaucoma diagnosis
One eye patients (patients whose other eye is blind for any reason).
Having very high IOP (above 30 mm Hg)
Patients who have currently received the maximum tolerated medical treatment (Maximum Tolerated Medical Treatment), but despite the treatment, their IOP has not been controlled.
History of laser trabeculoplasty or retina surgery
History of cataract surgery in the last 3 months
Active eye infection or inflammation
Narrow eye angle
Pregnant or lactating women
Any eye disease that prevents accurate IOP measurement. Like a corneal scar
Any unstable medical condition that prevents compliance with the scientific and ethical bases of the study protocol.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The method of random allocation will be using the block method and the use of random blocks. Blocks of four will be used for each intervention group. In this way, a person other than the doctor evaluating the outcome determines the treatment block with the help of random numbers obtained from the computer. Blocks of four will include: TCCT, TCTC, TTCC, CCTT, CTCT, CTTC.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
No. 7, Rajaei st 4, Shahid Rajaei Blvd., Zahedan city
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9819614968
Approval date
2023-02-01, 1401/11/12
Ethics committee reference number
IR.ZAUMS.REC.1401.392
Health conditions studied
1
Description of health condition studied
Primary open angle glaucoma
ICD-10 code
H40.1
ICD-10 code description
Open-angle glaucoma
Primary outcomes
1
Description
Percentage of eye pressure reduction in glaucoma patients
Timepoint
At the beginning of the study (before the start of the intervention) and 1 month and 6 months after the start of the treatment
Method of measurement
Goldman tonometer
Secondary outcomes
1
Description
visual acuity
Timepoint
At the beginning of the study (before the start of the intervention) and 1 month and 6 months after the start of the treatment
Method of measurement
Snellen vision measurement chart
Intervention groups
1
Description
Intervention group 1: The first intervention group: Selective Laser Trabeculoplasty group: a few minutes before the start of Selective Laser Trabeculoplasty, tetracaine drops of 0.5% are poured into the target eye. During the study, all patients in the SLT group underwent laser treatment (Elex SOLO-SLT 2011). It is a Nd:YAG (Q-switched) laser that emits 532 nm radiation with a pulse duration of 3 nanoseconds and a spot size of 400 micrometers and a pulse energy in the range of 0.2 to 1.7 mJ. With the patient sitting and the head placed in the slit lamp device, a goniolens (SLT-Retinal BD10052) is placed on the patient's eye. After that, the laser will be focused on the trabecular meshwork. The entire width of the trabecular mesh with a spot size of 400 µm is irradiated with each pulse. The laser energy will be initially set to 0.8 mJ and a laser pulse will be emitted at the 12 o'clock position. If the whitening of the trabecular meshwork does not occur or the cavitation bubble does not appear, the pulse energy will be increased by increasing 0.1 mJ until the formation of the bubble. Laser therapy is performed in 360 degrees.
Category
Treatment - Other
2
Description
Intervention group 2: Drug therapy group: In the drug therapy group, based on the guidelines provided in the ophthalmology reference books, the first step is to start the treatment with an ophthalmic prostaglandin analog such as latanoprost eye drops (containing 0.005% latanoprost - Sina darou Company). The second step, if the treatment goal is not met during the one-month follow-up, adding a beta-blocker such as timolol eye drops (containing 0.5% timolol maleate - Sina darou Co. with the brand name Optimol) or betaxolol eye drops (containing 0.5% betaxolol hydrochloride - Co. Sina darou will be under the brand name Betaxol). The third step will be brimonidine eye drops (containing 0.2% brimonidine tartrate - Sina darou company under the brand name Brimogan) and the fourth step will be adding dorzolamide eye drops (containing 2% dorzolamide hydrochloride - Sina darou company). Patients will be included in the study who have been newly diagnosed or who have not reached the target IOP determined by the doctor despite regular use of the standard medicine for the first line (latanoprost eye drops). The importance of how to take medicines is explained to the patients, and the patients are asked to record the side effects of the medicines, such as eye redness, tears, itchy eyes, dry eyes, etc. Patients are advised not to discontinue the drug in case of mild to moderate side effects such as mild redness or itchy eyes. In case of severe side effects such as headache, confusion or worsening of eye pain, contact the treating physician (if the treating physician confirms that the complication is caused by the use of the mentioned drug and continuing to use it for the overall health of the body and health The patient's eye is not suitable, the person is excluded from the study).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra eye hospital
Full name of responsible person
Tahereh Yavari
Street address
Shahid Motahari Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
ندارد. استعلام هم شد
Phone
+98 54 3321 9917
Fax
+98 54 3323 3550
Email
taherehyavari71@gmail.com
Web page address
https://eye.zaums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Nur Mohammad Bakhshani
Street address
2nd Floor, Central Headquarters Building, Zahedan University of Medical Sciences , Dr. Hesabi Square, Gulf of Fars Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
ندارد
Phone
+98 54 3337 2116
Fax
+98 54 3337 2116
Email
zaums.research@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?