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Comparison of Central Thickness Changes of Cornea in Linear Phacoemulsification with Torsional Phacoemulsification Surgery in Cataract Patients

Protocol summary

Study aim
Comparison of Central Thickness Changes of Cornea in Linear Phacoemulsification with Torsional Phacoemulsification Surgery 1 day and 1 week after the surgery
Design
Two intervention groups, Parallel Groups, Single Blind, Simply Randomized,30 patients
Settings and conduct
The patients with cataracts in both eyes who present to the Imamkhomeini hospital of Urmia, will undergo phacoemulsification in both eyes.Based on the statistical estimation, 30 patients will be chosen and the selection of each eye for eather linear or torsional surgery is simply randomized and the interval of the two surgeries will be two weeks.The aim to choose both eyes of each patient is to evoid the effects of variables such as age, gender, genetics and systemic diseases affecting the corneal thickness such as diabetes or any other undiagnosed disease,between the two groups.The patients are blind to the method of surgery on each eye.
Participants/Inclusion and exclusion criteria
Inclusion criteria : Patients over 40 years old, Cataracts in both eyes Exclusion criteria : Patients under 40 years old, corneal pathologies, poorly dilating pupil or posterior synechiae, pseudoexfoliation, subluxated lens, retinal pathology, glaucoma, diabetes mellitus, collagen vascular diseases, post refractive surgeries
Intervention groups
1)Linear Phacoemulsification Surgery, 2)Torsional Phacoemulsification Surgery
Main outcome variables
Central Corneal Thickness

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231125060168N1
Registration date: 2023-12-06, 1402/09/15
Registration timing: retrospective

Last update: 2023-12-06, 1402/09/15
Update count: 0
Registration date
2023-12-06, 1402/09/15
Registrant information
Name
Reza Soudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9931
Email address
‏soudi.r@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-26, 1402/08/04
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
2023-10-26, 1402/08/04
Actual recruitment end date
2023-11-25, 1402/09/04
Trial completion date
2023-12-03, 1402/09/12
Scientific title
Comparison of Central Thickness Changes of Cornea in Linear Phacoemulsification with Torsional Phacoemulsification Surgery in Cataract Patients
Public title
Comparison of Central Thickness Changes of Cornea in Linear Phacoemulsification with Torsional Phacoemulsification
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 40 years old Cataracts in both eyes
Exclusion criteria:
Age under 40 years old corneal pathologies poorly dilating pupil or posterior synechiae pseudoexfoliation subluxated lens retinal pathology glaucoma diabetes mellitus collagen vascular diseases post refractive surgeries
Age
From 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 30
More than 1 sample in each individual
Number of samples in each individual: 2
right eye - left eye
Actual sample size reached: 30
More than 1 sample in each individual
Actual sample size in each individual: 2
right eye - left eye
Randomization (investigator's opinion)
Randomized
Randomization description
From the patients with cataracts in both eyes who present to Imamkhomeini hospital of Urmia, 30 cases will be chosen based on inclusion or exclusion criteriae. The method used for randomizing the left or the right eye for torsional or linear surgery, is the black box. The box will contain 60 cards and each eye of each patient (left or right) with the name and family name, will be written on one card. Each time, one card will be taken out of the box and each eye of each patient coming out in the first sequence,will undergo surgery with one of the methods; and the eye coming out of the box in second sequence, will undergo surgery with the other type. Determining the method used for the first sequence is by flapping a coin.If the first sequence is torsional, the second sequence will actually be linear or vice versa.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patients who present to the hospital to undergo surgery in both eyes, are blind to the method of surgery on each eye.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committe of Imamkhomeini Hospital - Urmia University of Medical Sciences
Street address
Ershad Blvd - Ayatollah Modarres Blvd
City
Urmia
Province
West Azarbaijan
Postal code
8135157157
Approval date
2023-10-25, 1402/08/03
Ethics committee reference number
IR.UMSU.HIMAM.REC.1402.092

Health conditions studied

1

Description of health condition studied
Central Thickness Changes of Cornea
ICD-10 code
H18.23
ICD-10 code description
Secondary corneal edema

Primary outcomes

1

Description
Central Corneal Thickness
Timepoint
Before the surgery, 24 Hours later and 1 week later the surgery
Method of measurement
Pachymeter

Secondary outcomes

1

Description
Best Corrected Visual Acuity
Timepoint
Before Surgery, 24 Hours later and 1 week later the surgery
Method of measurement
Snellen Chart

Intervention groups

1

Description
The First Intervention Group : The first group consists of 15 patients who undergo torsional phacoemulsification surgery.The central thickness of cornea in each patient is measured, once 24 hours and once 1 week later,using the pachymeter.
Category
Treatment - Surgery

2

Description
The Second Intervention Group : The second group consists of 15 patients who undergo linear phacoemulsification surgery.The central thickness of cornea in each patient is measured, once 24 hours and once 1 week later,using the pachymeter.
Category
Treatment - Surgery

3

Description
Control group: The control group consists of 30 eyes of 15 patients which will undergo surgery in two parallel torsional and linear groups and the central thickness of cornea of each eye will be measured using the pachymeter.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Imamkhomeini Hospital
Full name of responsible person
Reza Soudi
Street address
Ershad Blvd - Ayatollah Modarres Blv
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3346 9931
Fax
+98 44 3346 9935
Email
soudi.r@umsu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Saber Gholizadeh
Street address
Urjans Ave, Resalat Blv, Setad Olumpezeshki
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Fax
+98 44 3223 4897
Email
info@umsu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Reza Soudi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Ershad Blvd - Imamkhomeini Hospital
City
Urmia
Province
West Azarbaijan
Postal code
8135157157
Phone
+98 44 3346 9931
Fax
+98 44 3346 9935
Email
‏soudi.r@umsu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Reza Soudi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Ershad Blvd - Imamkhomeini Hospital
City
Urmia
Province
West Azarbaijan
Postal code
8135157157
Phone
+98 44 3346 9931
Fax
+98 44 3346 9935
Email
‏soudi.r@umsu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Reza Soudi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Ershad Blvd - Imamkhomeini Hospital
City
Urmia
Province
West Azarbaijan
Postal code
8135157157
Phone
+98 44 3346 9931
Fax
+98 44 3346 9935
Email
‏soudi.r@umsu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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