Comparison of the Efficacy of Diclofenac 0.1% and Nepafenac 0.1% on anterior chamber cells in patients Undergoing Cataract Surgery: a Prospective clinical practice trial
: To compare the efficacy of topical nepafenac 0.1 % and diclofenac 0.1% eye drops in reducing the aqueous cells in the anterior chamber in an uneventful post cataract surgery.
Design
Sample size= 70 patients, Probability sampling by simple randomization (via computer-generated no.), parallel-group, non-blind, clinical practice trial
Settings and conduct
The study was conducted an an Eye dept. of Nowshera Medical College
Participants/Inclusion and exclusion criteria
Patients’ ≥ 50 yrs. Both males and females with visually significant senile-cataracts under-going phaco-emulsification with intra-ocular lens implantation were enrolled.
Exclusion criteria were any past intra-ocular surgery, any history of any intra-ocular inflammatory diseases, traumatic globe injuries, corneal disorders impairing the view, any glaucomatous diseases of eye, pseudo-exfoliation, any retinal/macular abnormalities, such as macular edema due to other etiologies or epi-retinal membranes or any age-related maculopathy. Those not willing to follow the study protocols and requirements of follow up were also excluded. Those who were pre-diabetics and confirmed diabetics, with systemic autoimmune/inflammatory disorders or any history of allergic reaction to the study drugs or other NSAIDs were also expelled. Oral steroids or NSAIDs intake was prohibited for the participants throughout the trial duration. Patients with eventful phaco surgery such as posterior-capsular tear, vitreous-prolapse or post-operative fibrinous reactions were not recruited for the study.
BCVA (visual acuity) converted into Log MAR; CMT measured in microns by SD-OCT; Mean AC cells
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220607055097N2
Registration date:2022-07-05, 1401/04/14
Registration timing:retrospective
Last update:2022-07-05, 1401/04/14
Update count:0
Registration date
2022-07-05, 1401/04/14
Registrant information
Name
Adnan Ahmad
Name of organization / entity
Nowshera Medical College, Nowshera
Country
Pakistan
Phone
+92 91 2586506
Email address
dradnanahmad@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-01, 1399/10/12
Expected recruitment end date
2021-12-31, 1400/10/10
Actual recruitment start date
2021-01-01, 1399/10/12
Actual recruitment end date
2021-12-31, 1400/10/10
Trial completion date
2022-01-30, 1400/11/10
Scientific title
Comparison of the Efficacy of Diclofenac 0.1% and Nepafenac 0.1% on anterior chamber cells in patients Undergoing Cataract Surgery: a Prospective clinical practice trial
Public title
Effect of Diclofenac 0.1% Vs. Nepafenac 0.1% on anterior chamber reaction in post-operative (cataract) cases.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients’ ≥ 50 yrs.
Both males and females
with visually significant senile-cataracts under-going phacoemulsification with intra-ocular lens implantation
Exclusion criteria:
Any past intra-ocular surgery
Any history of any intra-ocular inflammatory diseases,
Traumatic globe injuries
Corneal disorders impairing the view
Any glaucomatous diseases of eye
Pseudo-exfoliation cataracts
any retinal/macular abnormalities, such as macular edema due to other etiologies or epi-retinal membranes or any age-related maculopathy.
Those not willing to follow the study protocols and requirements of follow up
Those who were pre-diabetics and confirmed diabetics
Those with systemic autoimmune/inflammatory disorders or any history of allergic reaction to the study drugs or other NSAIDs
Patients with eventful phaco surgery such as posterior-capsular tear, vitreous-prolapse or post-operative fibrinous reactions
Age
From 50 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Method= Simple randomization, Unit= Individual, Tool= computer software, Random sequence created via computer software, allocation concealment not done
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Prospective, randomized clinical practice trial
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Ethical Review Board of Nowshera Medical College
Street address
Mardan road, near Kabul river, Nowshera
City
Nowshera
Postal code
24110
Approval date
2021-01-01, 1399/10/12
Ethics committee reference number
NO: 0337 /R&D/IERB/NMC
Health conditions studied
1
Description of health condition studied
Anterior chamber reaction inside the eye after cataract surgery
ICD-10 code
H59.039
ICD-10 code description
Cystoid macular edema following cataract surgery, unspecified eye
Primary outcomes
1
Description
BCVA (visual acuity) in Log MAR
Timepoint
Baseline, 1st day, 2nd, 4th and 8th week
Method of measurement
VA measured with Snellen chart and than converted into Logarithm of minimum angle of resolution
2
Description
Anterior chamber cells
Timepoint
Baseline, 1st day, 2nd, 4th and 8th week
Method of measurement
Slit lamp examination method by counting the no. of cells in anterior chamber of eye
3
Description
Central macular thickness
Timepoint
Baseline, 1st day, 2nd, 4th and 8th week
Method of measurement
Central macular thickness was measured in microns by SD-OCT
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Topical Diclofenac 0.1% eye drops (TD), used 4 times/day for 4 weeks in the operated eyes
Category
Treatment - Drugs
2
Description
Intervention group: Topical Nepafenac 0.1% (TN) eye drops, used 3 times/day for 4 weeks in the operated eyes
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Nowshera Medical College/ Qazi Hussain Ahmad Medical Complex
Full name of responsible person
Mubashir Rehman
Street address
Mardan road, near Kabul river, Nowshera
City
Nowshera
Postal code
24110
Phone
+92 923 9220325
Email
drmubashirrehman78@gmail.com
Web page address
https://nmcn.edu.pk/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nowshera Medical College/ Qazi Hussain Ahmad Medical Complex
Full name of responsible person
Nizam Darwesh
Street address
Mardan road, near Kabul river, Nowshera
City
Nowshera
Postal code
24110
Phone
+92 923 9223025
Email
info@nmcn.edu.pk
Web page address
https://nmcn.edu.pk/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nowshera Medical College/ Qazi Hussain Ahmad Medical Complex
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
Nowshera Medical College, Nowshera
Full name of responsible person
Adnan Ahmad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Civil colony
City
Peshawar
Province
Khyber Pukhtoonkhwa
Postal code
25000
Phone
+92 91 2586506
Fax
Email
dradnanahmad@hotmail.com
Web page address
https://nmcn.edu.pk/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nowshera Medical College, Nowshera
Full name of responsible person
Adnan Ahmad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Civil colony
City
Peshawar
Province
Khyber Pukhtoonkhwa
Postal code
25000
Phone
+92 91 2586506
Fax
Email
dradnanahmad@hotmail.com
Web page address
https://nmcn.edu.pk/
Person responsible for updating data
Contact
Name of organization / entity
Nowshera Medical College, Nowshera
Full name of responsible person
Adnan Ahmad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Civil colony
City
Peshawar
Province
Khyber Pukhtoonkhwa
Postal code
25000
Phone
+92 91 2586506
Fax
Email
dradnanahmad@hotmail.com
Web page address
https://nmcn.edu.pk/
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
confidential
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All collected
When the data will become available and for how long
3 months after publication till 1 year post publication
To whom data/document is available
Academic institutions
Under which criteria data/document could be used
For research purposes
From where data/document is obtainable
Via emails upon request
What processes are involved for a request to access data/document
By sending request via email and purpose of needing the data/documents