Objective: In this study we aim at investigating the role of acupuncture as a treatment modality with minimal side effects in primary open angle glaucoma (POAG).
Design: In this quasi-experimental study 33 patients with primary open angle glaucoma visiting the glaucoma clinic are randomly selected and examined for eligibility. Setting and conduct: acupuncture treatment is performed for all participants and they also receive all required medications for glaucoma during the treatment course. Participants including major eligibility criteria: Over 18 years of age, confirmed primary open-angle glaucoma (POAG), willing to participate in the study. Intervention: acupuncture treatment is given 3 times a week for four weeks and the patients are followed up monthly up to three months. Needle insertion points are fixed in all sessions and are 11 points, bilaterally inserted (22 points). Intraocular pressure (IOP) measurement is performed in each visit.
Main outcome variables: patients are followed up after one week and then monthly up to three months, undergoing all ophthalmologic examinations including IOP measurement for both eyes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015062911912N3
Registration date:2015-12-01, 1394/09/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-01, 1394/09/10
Registrant information
Name
Hamidreza Bahrami Taghanaki
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1841 5666
Email address
bahramihr@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council of Mashhad University of Medical Sciences
Expected recruitment start date
2014-04-09, 1393/01/20
Expected recruitment end date
2015-12-31, 1394/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of acupuncture in the treatment of open-angle glaucoma in Mashhad city
Public title
Studying the effect of acupuncture in the treatment of glaucoma
Purpose
Treatment
Inclusion/Exclusion criteria
Major eligibility criteria: Over 18 years of age; confirmed primary open-angle glaucoma (POAG); willing to participate in the study
Major exclusion criteria: suspected of having other types of glaucoma; history of ophthalmologic disease other than POAG such as corneal ulcer, corneal scar, keratoconus, etc, history of eye surgery in the previous three months; any type of ocular or periocular infection or inflammation in the previous month; anticoagulant or antiplatelet medications use; intraocular pressure (IOP) more than 25mmHg despite conventional therapy at the inclusion time; severe or advanced POAG and history of any systemic disease influencing IOP.
Age
From 17 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
33
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
1
Registry name
None
Secondary trial Id
none
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Deputy of Research, GHoreyshi building, Daneshgah St.,
City
Mashhad
Postal code
Approval date
2014-01-15, 1392/10/25
Ethics committee reference number
920048
Health conditions studied
1
Description of health condition studied
Primary open angle glaucoma
ICD-10 code
H40, H42
ICD-10 code description
Glaucoma, Glaucoma in diseases classified elsewhere
Primary outcomes
1
Description
Intraocular pressure (IOP)
Timepoint
after one week and then monthly up to three months
Method of measurement
Goldmann applanation tonometer
Secondary outcomes
1
Description
Intraocular pressure of the right and left eye
Timepoint
after one week and then monthly up to three months