- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06913556
Comparing Effect of Hylorunic Acid and Lipid-coated Carbomer Gel on Dry Eyes After Phacoemulsification in DP
March 29, 2025 updated by: Muhammad Naveed Babur, Superior University
Comparing Effect of Hylorunic Acid and Lipid-coated Carbomer Gel on Dry Eyes After Phacoemulsification in Diabetic Patients
In this research checked the curative effect of two different artificial tears on dry eyes after phacoemulsification was checked.
In research, the randomized control trial methodology is used
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan
- Shaheen welfare hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Patients aged 50-70
- Both gender male /female
Exclusion Criteria:
- Patients who have acute dry eye condition before phacoemulsification cataract surgery.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: preoperative dry eyes
|
In group 1 we access preoperative dry eyes condition and postoperatively we access the condition in 2nd and 4th week with the use of Hylorunic acid lubricant.
|
|
Experimental: lipid coated carbomer gel eye drops
|
In group 2 we prescribe the lipid coated carbomer gel eye drops and access dry eyes condition preoperative and postoperative on 2nd and 4th week and check the curative effect of drop.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Tear Break-Up Time (TBUT) test
Time Frame: 12 Months
|
The Tear Break-Up Time (TBUT) test measures how long the tear film on the eye surface remains intact before it breaks up, with a normal TBUT typically being 10 seconds or more.
A shorter TBUT suggests tear film instability and potential dry eye issues.
|
12 Months
|
|
Schirmer test
Time Frame: 12 Months
|
In a Schirmer test, a score of greater than 10 mm of moistened area on the filter paper after 5 minutes is considered normal, while less than 10 mm suggests dry eyes
|
12 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 20, 2025
Primary Completion (Estimated)
June 20, 2025
Study Completion (Estimated)
February 20, 2026
Study Registration Dates
First Submitted
March 29, 2025
First Submitted That Met QC Criteria
March 29, 2025
First Posted (Actual)
April 6, 2025
Study Record Updates
Last Update Posted (Actual)
April 6, 2025
Last Update Submitted That Met QC Criteria
March 29, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MSRSW/Batch-Fall23/807
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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