Determination of the effect of% 0.05 cyclosporine on dry eye after cataract surgery
Design
This clinical trial study was performed on 50 patients who were candidates for cataract surgery referred to Bu Ali Sina Hospital in Sari with a control group with parallel, single-blind, randomized phase 2 on 50 patients for randomization of random allocation software.
Settings and conduct
The study site of Bu Ali Hospital in Sari was studied on 50 patients who were divided into two groups of 25. Group T and group C, intervention group or C in addition to a fixed treatment regimen of 0.05% cyclosporine drops, 4 times a day for 4 weeks and in the control group or Artificial tear drops were used 4 times a day for 4 weeks. Patients were followed up at intervals of day 1, day 7 and day 30 after surgery, and on day 30 after surgery, the necessary dry eye examinations were performed for patients at Bu Ali Sina Hospital. Participating in the study and clinical caregiver The evaluator in this study will be blind. Only the methodological consultant had access to the list.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Candidate patients for cataract surgery over 40 years
Exclusion criteria: Significant preoperative dry eye (Tbut ≤10, ST-I≤10), Presence of systemic diseases, Use of drugs with the effect of dry eye, Existence of complications during or after cataract surgery, Pregnant and lactating mothers
Intervention groups
Intervention group: Includes group therapy patients who used% 0.05 cyclosporine drops in addition to the fixed post-cataract treatment regimen (betamethasone / chloramphenicol).
Control group: includes group therapy patients who, in addition to a fixed treatment regimen after cataract surgery (betamethasone / chloramphenicol), also used tyrolose drops or artificial tears.
Main outcome variables
Dry eyes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211227053548N1
Registration date:2022-01-19, 1400/10/29
Registration timing:prospective
Last update:2022-01-19, 1400/10/29
Update count:0
Registration date
2022-01-19, 1400/10/29
Registrant information
Name
Hanieh Ahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3320 3358
Email address
h.ahmadih123@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of cyclosporine % 0/05 compared with tearlose on post cataract surgery dry eye
Public title
The effect of cyclosporine eye drops compared to artificial tears for dry eye after cataract surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate patients for cataract surgery
Age over 40 years
Exclusion criteria:
Sever dry eye(Tbut ≤10 , ST-I≤10)
Existence of systemic diseases such as uncontrolled diabetes ,Lupus, rheumatoid arthritis and ...
Use of drugs with the effect of dry eye, such as anti-glaucoma drugs
Complication in or post cataract surgery:endophthalmitis,nucleous drop,keratopathy,macular edema and retinal detachment
Pregnant and breast feeding mother
Age
From 40 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization method is used to randomized the patients. For randomization, we visited the www.sealedenvelope.com, then randomization tab and make a list option were selected, the number of intervention groups, sample size, block size (4) were entered the intended locations, then a random list containing the pattern of patient allocation was obtained in two groups
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo is prepared by the Department of Pharmacy, School of Pharmacy, Mazandaran University of Medical Sciences, Iran in a completely similar way to the drug (cyclosporine). The droppers (containing medicine or placebo) will be provided to eligible patients by the ward pharmacy based on a random allocation list. Patients, physicians, pharmacists, and ward nurses are unaware of the groups. Unique codes are used instead of letters to blind groups.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran university ethics committee
Street address
Joybar three way,mazandaran univercity of medical sciences
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2021-09-01, 1400/06/10
Ethics committee reference number
IR.MAZUMS.REC.1400.435
Health conditions studied
1
Description of health condition studied
Post cataract surgery dry eye
ICD-10 code
H26
ICD-10 code description
Other cataract
Primary outcomes
1
Description
Dry eye
Timepoint
1mounth post cataract surgery
Method of measurement
Osid,tbut test,schirmer1 test
Secondary outcomes
1
Description
Eye irritation
Timepoint
One day,one week and 1mounth post surgery
Method of measurement
Osid
2
Description
eye's pain
Timepoint
One day,one week and 1mounth post surgery
Method of measurement
Osid
3
Description
eye redness
Timepoint
One day,one week and 1mounth post surgery
Method of measurement
Osid
Intervention groups
1
Description
Intervention group: Cyclosporine drops of% 0.05, which is given to the patient every 6 hours every 6 hours after surgery for a fixed treatment regimen, including steroid eye drops, and the drops are the product of Sina Daru Company. Patients are fully followed up at intervals of day 1, day 7 and day 30 after surgery, and on day 30 after surgery, the necessary dry eye examinations are performed for patients at Bu Ali Sina Hospital.
Category
Treatment - Drugs
2
Description
Control group: Adding drops of Tyrol or artificial tears, which are given to the patient every 6 hours every 6 hours after surgery for a fixed period of 4 weeks, including steroid eye drops, and the drops are the product of Sina Daroo Company. Patients are fully followed up at intervals of day 1, day 7 and day 30 after surgery, and on day 30 after surgery, the necessary dry eye examinations are performed for patients at Bu Ali Sina Hospital. It is administered every 6 hours after surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Boalisina hospital
Full name of responsible person
Hanieh ahmadi
Street address
Pasdaran blv
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3010
Fax
+98 11 3334 3012
Email
Diako112358@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hanieh ahmadi
Street address
Joybar 3 way
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4000
Fax
+98 11 3335 2725
Email
diako112358@gmail.com
Grant name
Ww
Grant code / Reference number
344
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Ghh
Proportion provided by this source
4
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hanieh ahmadi
Position
Assistan professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Piroozi
City
Sari
Province
Mazandaran
Postal code
4818768893
Phone
+98 11 3320 3354
Email
Diako112358@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hanieh ahmadi
Position
Assistan profossor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Piroozi
City
Sari
Province
Mazandaran
Postal code
4818768893
Phone
+98 11 3320 3354
Email
Diako112358@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hanieh ahmadi
Position
Assistan proffosor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Piroozi
City
Sari
Province
Mazandaran
Postal code
4818768893
Phone
+98 11 3320 3354
Email
Diako112358@gmail.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
It is confidential
Study Protocol
No - There is not 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