Study the effect of pre-operative doses of betamethasone acetate 0.1% on dry eye control and visual acuity after cataract surgery in patients referring to Khatam-al-Anbia hospital in 2016-2017
Cataract is one of the main causes of visual impairment and blindness in the world and dry eye and visual impairment occur after cataract surgery. The aim of this study is to compare the effects of pre-operative doses of betamethasone acetate 0.1% and placebo on controlling dry eye and improvement of visual acuity after cataract surgery.
In this clinical trial study 62 patients being candidate for cataract surgery were divided into two groups of 31 patients. Drops of A or B were administered 4 times a day. These drops contained either betamethasone 0.1% or normal saline. Postoperative follow up was performed on days 1, 7 and one month after surgery. Dry eyes symptoms were evaluated by the OSDI questionnaire, Schirmer and TBUT test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017103037105N1
Registration date:2017-11-10, 1396/08/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-11-10, 1396/08/19
Registrant information
Name
Seyedeh Zeinab Hashemi Javaheri
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3608 2257
Email address
hashemiz891@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2016-11-04, 1395/08/14
Expected recruitment end date
2017-03-05, 1395/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of pre-operative doses of betamethasone acetate 0.1% on dry eye control and visual acuity after cataract surgery in patients referring to Khatam-al-Anbia hospital in 2016-2017
Public title
Study the effect of pre-operative doses of betamethasone acetate 0.1% on dry eye control and visual acuity after cataract surgery in patients referring to Khatam-al-Anbia hospital in 2016-2017
Purpose
Prevention
Inclusion/Exclusion criteria
Criteria for entering the study: age-related cataract; requiring ophthalmic surgery for cataract surgery.
Exit criteria: significant eye disease; systemic rheumatologic diseases, and diabetes; the use of drowsiness drugs; long history of long-term eye drops such as glaucoma drugs and the complications of cataract surgery during or after from surgery.
Age
From 40 years old to 90 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad Uiversity of Medical Ssiences
Street address
Mashhad Uiversity of Medical Ssiences, Vakilabad Blvd.
City
Mashhad
Postal code
Approval date
2016-06-22, 1395/04/02
Ethics committee reference number
IR.MUMS.SM.REC.1395.76
Health conditions studied
1
Description of health condition studied
Cataract
ICD-10 code
H26.9
ICD-10 code description
Cataract, unspecified
Primary outcomes
1
Description
Eye dryness
Timepoint
Before surgery and 1, 7, 30 days after surgery
Method of measurement
OSDI questionare was filled by patients and Shirmer test was performed with Schirmer paper, TBUT tes was performed with slit lamp , BCVA measured by optometrist
Secondary outcomes
empty
Intervention groups
1
Description
Control group: normal salin 0.9% was prescribed 3 days before the date considered for surgery, with the frequency 4 times a day and every time a drop in the desired eye
Category
Placebo
2
Description
Intervention group: betamethasone acetate 0.1% ,was prescribed 3 days before the date considered for surgery, with the frequency 4 times a day and every time a drop in the desired eye
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam-al-Anbia hospital
Full name of responsible person
Street address
Khatam-al-Anbia hospital, Shahid Gharani Blvd.
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad Uiversity of Medical Ssiences
Full name of responsible person
Dr. Saeed Shokoohirad
Street address
Mashhad University of Medical Sciences, Daneshgah St.
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad Uiversity of Medical Ssiences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyedeh Zeinab Hashemi Javaheri
Position
Medical intern
Other areas of specialty/work
Street address
Khatam-al-Anbia hospital, Shahid Gharani Blvd.
City
Mashhad
Postal code
Phone
+98 51 3608 2257
Fax
Email
hashemiz58@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Saeed Shokoohi Rad
Position
Ophtalmologist
Other areas of specialty/work
Street address
Khatam-al-Anbia hospital, Shahid Gharani Blvd.
City
Mashhad
Postal code
Phone
+98 51 3728 9981
Fax
Email
shokoohirads@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyedeh Zeinab Hashemi Javaheri
Position
Medical intern
Other areas of specialty/work
Street address
Khatam-al-Anbia hospital, Shahid Gharani Blvd.
City
Mashhad
Postal code
91656-17178
Phone
+98 51 3608 2257
Fax
Email
hashemiz58@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)