Determining the Influence of Dry Eye Disease and Artificial Tear eye drop on the Biometry Repeatability and Accuracy in Patients with Cataract in the ophthalmology clinic of Farshchian (Sina) Hospital in 2024-2025
Design
Clinical trial in a group of 20 bilateral cataract surgery candidates (40 eyes) with dry eye disease referred to Hamedan Sina Hospital in 2024-25, with a control group, with parallel groups, not randomized and without blinding
Settings and conduct
In patients aged 50 to 70 years with bilateral cataracts, routine preoperative examinations will be performed. Schirmer test, TBUT test, and corneal staining will be used to determine the presence and severity of dry eye disease. Biometry will be performed twice using IOLMaster 500, 15 minutes apart, for one eye without artificial tears and ten minutes after applying artificial tear drop in the opposite eye, and this will be repeated. All patients will undergo Phaco cataract surgery under local anesthesia, and one month after surgery, patients' refraction will be measured and their spherical equivalent will be compared with the expected one.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients aged 50 to 70 years with bilateral cataracts and mild to moderate dry eye disease without any pathology affecting biometry or prior ocular surgery and with consent to participate in the study
Exclusion criteria:Any complications during or after surgery or failure to attend follow-up visits
Intervention groups
Patients aged 50 to 70 years with bilateral cataracts and mild to moderate dry eye disease will be instilled with artificial tear drop in one eye before biometry, and the patient's refraction will be measured and the patients' SE will be compared with the expected SE in both eyes one month later.
Investigating the Influence of Dry Eye Disease and Artificial Tear eye drop on the Biometry Repeatability and Accuracy in Patients with Cataract
Public title
Investigating the Influence of Dry Eye Disease and Artificial Tear eye drop on the Biometry Repeatability and Accuracy in Patients with Cataract
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 50 to 70 years with bilateral cataract and mild to moderate Dry eye disease
Informed consent to participate in the study
Absence of pathologies influencing biometry such as keratoconus, corneal scar, pathologic myopia, nanophthalmus, etc
Absence of prior ocular surgical history
Exclusion criteria:
Any intra- or postoperative complication occurance
Patient's failure to attend follow-up visit
Age
From 50 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
both eyes in a patient with bilateral cataract and dry eye disease
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan university of medical sciences
Street address
Hamedan University of Medical Sciences, Shahid Fahmid Blvd., Pajouhesh Square
City
Hamedan
Province
Hamadan
Postal code
6517838736
Approval date
2025-02-16, 1403/11/28
Ethics committee reference number
IR.UMSHA.REC.1403.837
Health conditions studied
1
Description of health condition studied
cataract
ICD-10 code
H26
ICD-10 code description
Other cataract
2
Description of health condition studied
Dry eye disease
ICD-10 code
H04.12
ICD-10 code description
Dry eye syndrome
Primary outcomes
1
Description
spherical equivalent
Timepoint
At the beginning of the study and one month after surgery
Method of measurement
Topcon RM8000 autorefractometer
2
Description
Anterior chamber depth
Timepoint
At the beginning of the study and one month after surgery
Method of measurement
IOL Master 500
3
Description
Axial length
Timepoint
At the beginning of the study and one month after surgery
Method of measurement
IOL Master 500
4
Description
mean keratometry
Timepoint
At the beginning of the study and one month after surgery
Method of measurement
Topcon RM8000 autorefractometer
5
Description
corneal astigmatism
Timepoint
At the beginning of the study and one month after surgery
Method of measurement
Topcon RM8000 autorefractometer
6
Description
Dry eye disease severity
Timepoint
before intervention
Method of measurement
Schirmer test, TBUT test, and corneal staining
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: primary biometry using IOLMaster-500 and then Instilling tearlose (Sinadaro) artificial tear drop 10 minutes before second biometry in one of a patient's eyes and one month after cataract surgery, measuring refraction and SE using auto refractometer
Category
Prevention
2
Description
Control group: primary biometry using IOLMaster-500 and then not instilling Tearlose (Sinadaro) artificial tear drop 10 minutes before second biometry in one of a patient's eyes and one month after cataract surgery, measuring refraction and SE using auto refractometer
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina (Farshchian) hospital
Full name of responsible person
Elham Soltani
Street address
Pastor Crossroads
City
Hamedan
Province
Hamadan
Postal code
6516848741
Phone
+98 81 3825 4083
Fax
+98 81 3825 4083
Email
e.soltani@umsha.ac.ir
Web page address
https://fsh.umsha.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Alireza Soltanian
Street address
Vice President of Research and Technology office, university headquarters 4th floor, Shahid Fahmideh Blvd.
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۸۴
Phone
+98 81 3131 4058
Fax
+98 81 3131 4058
Email
Fanavari@umsha.ac.ir
Web page address
https://research.umsha.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Elham Soltani
Position
Associate
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Mirzadeh Eshghi street , Farshchian (Sina) Hospital
City
Hamadan
Province
Hamadan
Postal code
6516848741
Phone
+98 81 3826 5706
Fax
Email
e.soltani@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Elham Soltani
Position
Associate
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Mirzadeh Eshghi street , Farshchian (Sina) Hospital
City
Hamadan
Province
Hamadan
Postal code
6516848741
Phone
+98 81 3826 5706
Fax
Email
e.soltani@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Elham Soltani
Position
Associate
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Mirzadeh Eshghi street , Farshchian (Sina) Hospital
City
Hamadan
Province
Hamadan
Postal code
6516848741
Phone
+98 81 3826 5706
Fax
Email
e.soltani@umsha.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