Evaluation the effect of topical prednisolon acetate 1% on the pupillary diameter and ocular pain after uncomplicated cataract surgery in diabetic and non diabetic patients
T o assess the effect of pre-operative prednisolone acetate 1% on maintenance of intra-operative mydriasis and post-operative pain in uncomplicated cataract surgery in diabetic and non- diabetic patients: a randomized trial.
Design
This clinical trial ( phase 3) consists of 4 groups: 2 interventions and 2 controls. Intervention 1 or A were non- diabetic patients who received prednisone 1% eye drop, control 1 or B were non-diabetic patients who received artificial tears as placebo. Intervention 2 or C were non- diabetic patients who received prednisone 1% eye drop, control 2 or D were non-diabetic patients who received artificial tears as placebo. Patients' randomization was perforemed by the table of random numbers. sample size was 80(20 participants in each group).
Settings and conduct
This prospective study is conducted on patients over 40 years of age with cortical cataract, posterior subcapsular, or nucleic sclerosis, which are characterized by general anesthesia phacoemulsification surgery in Khatam al-Anbia (PBUH) Hospital
Participants/Inclusion and exclusion criteria
In diabetic and non diabetic group:
Inclusion criteria:Patients over 40 years old with cortical cataract, posterior subcapsular or grade 2 to 3 nuclear sclerosis with indication of phacoemulsification surgery under general anesthesia;
Exclusion criteria: Previous history of intraocular surgery; collagen vascular diseases; mature cataract ;History of or current use of non-steroid drugs, alpha-blocker, anti-glycemic drugs; ; History of Uveitis
Intervention groups
Non- Diabetic patients: group A received prednisone acetate 1% topical eye drop, group B received artificial tear drop as placebo. Diabetic patients : group C received prednisolne acetate 1% topical eye drop and group D used artificial tear drop as placebo.
Main outcome variables
pupil size; pain, photophobia; itching;foreign body sensation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180205038617N1
Registration date:2018-04-09, 1397/01/20
Registration timing:retrospective
Last update:2018-04-09, 1397/01/20
Update count:0
Registration date
2018-04-09, 1397/01/20
Registrant information
Name
Abolfazl Hoseinzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3840 8480
Email address
Hoseinzadeha1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-13, 1395/12/23
Expected recruitment end date
2018-11-11, 1397/08/20
Actual recruitment start date
2017-06-22, 1396/04/01
Actual recruitment end date
2018-01-20, 1396/10/30
Trial completion date
empty
Scientific title
Evaluation the effect of topical prednisolon acetate 1% on the pupillary diameter and ocular pain after uncomplicated cataract surgery in diabetic and non diabetic patients
Public title
Effect of prednisolon acetete drop on pupil dilation and ocular pain after cataract surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
In non- diabetic group: Patients over 40 years old with cortical cataract, posterior subcapsular or grade 2 to 3 nuclear sclerosis that have indication of phacoemulsification surgery with general anesthesia
In diabetic group: Patients over 40 years old with cortical cataract, posterior subcapsular or grade 2 to 3 nuclear sclerosis that have pseudoexfuliation or non proliferative diabetic retinopathy and have indication of phacoemulsification surgery with general anesthesia
Exclusion criteria:
History of previous intraocular surgery
collagen vascular disease
history of previous or current topical steroids, alphablocker or antiglaucoma medication
history of previous or current systemic steroid use
history of uveitis
mature cataract
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:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
If non-diabetic patients have inclusion criteria, they will be divided in to 2 groups of A and B through simple random sampling and using envelopes. Also, diabetic patients that have inclusion criteria will be divided in to 2 groups of C and D through simple random sampling and using envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients in control group were given placebo which its appearance was the same as the medication which was administered for intervention group. All participants, researcher, surgeons and outcome investigator were blind about the medication were used for each patient.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Khatamolanbia Hospital, Gharani street
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Approval date
2017-01-28, 1395/11/09
Ethics committee reference number
IR.MUMS.fm.REC.1395,119
Health conditions studied
1
Description of health condition studied
Effect of topical dipped prednisolone acetate 1% on pupil dilatation and pain after uncomplicated cataract surgery
ICD-10 code
H25.0
ICD-10 code description
Age-related incipient cataract
Primary outcomes
1
Description
Horizontal pupilary diameter
Timepoint
The diameter of the pupilary horizontal diameter is measured at the beginning and at the end of the operation using caliber and is divided into two groups up and down six millimeters.
Method of measurement
Caliber
2
Description
The score of post-operative pain which is measured by Visual Analog Scale for pain questionnaire.
Timepoint
24 hours after surgery
Method of measurement
Score of Visual Analog Scale for pain questionnaire
Secondary outcomes
1
Description
post operative photophobia
Timepoint
24 hours after surgery
Method of measurement
Visual Analogue Scale for pain questionnaire
2
Description
Foreign body sensation
Timepoint
24 hours after surgery
Method of measurement
Visual Analogue Scale for pain questionnaire
3
Description
Itching
Timepoint
24 hours after surgery
Method of measurement
Visual Analogue Scale for pain questionnaire
Intervention groups
1
Description
Intervention 1: Non-diabetic patients who recieve topical prednisone acetate 1% drop, every six hours, 24 hours before surgery. Patients are advised to shake the bottle before using. The administered drop is produced by Sinadaroo company.
Category
Prevention
2
Description
Intervention group: Diabetic patients who receive topical prednisone acetate 1% every six hours, 24 hours before surgery. Patients are advised to shake the bottle before using. The administered drop is produced by Sinadaroo company.
Category
Prevention
3
Description
Control group1: Non-Diabetic patients who receive preservative- free artificial tears every six hours, 24 hours before surgery. The administered drop is produced by Sinadaroo company.
Category
Placebo
4
Description
Control group2: Diabetic patients who receive preservative- free artificial tears every six hours, 24 hours before surgery. The administered drop is produced by Sinadaroo company.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam al-anbya hospital
Full name of responsible person
Hamid Gharaee
Street address
Gharani blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 1401
Email
Gharaee_oph@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamidreza Gharaee
Street address
Ghareni Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 1401
Email
Gharaee_oph@yahoo.com
Grant name
Research deputy of Mashhad University of Medical Sciences
Grant code / Reference number
941814
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
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
Mashhad University of Medical Sciences
Full name of responsible person
Hoseinzadeh Abolfazl
Position
Residence
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
No23,Besat ave.,Ahmadabad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9175934333
Phone
+98 51 3840 2924
Email
Hoseinzadeha1@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hoseinzadeh abolfazl
Position
Residence
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
No23,Beesat Blvd,Ahmadabad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9175934333
Phone
+98 51 3840 2924
Email
Hoseinzadeha1@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hoseinzadeh Abolfazl
Position
Residence
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
No.23,Beesat Blvd,Ahmadabad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9175934333
Phone
+98 51 3840 2924
Email
Hoseinzadeha1@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Total data of patients and research result are shareable after undetectabling of patient since 2019
When the data will become available and for how long
From2019
To whom data/document is available
Researchers of academic center only
Under which criteria data/document could be used
Clinical and practical usage is okay
From where data/document is obtainable
Email:Hoseinzadea1@mums.ac.ir Tel:00989122276382
What processes are involved for a request to access data/document