A Comparison Between the Ocular Surface of Different Concentrations of Benzalkonium Chloride Preservative in Postoperative Topical Medications After Cataract Surgery
Dexamethasone, tobramycin, netilimicin
Eye Diseases
+ Lacrimal Apparatus Diseases
+ Dry Eye Syndromes
Treatment Study
Summary
Study start date: January 10, 2024
Actual date on which the first participant was enrolled.This study is focused on understanding how different concentrations of a preservative called Benzalkonium Chloride (BAK) in eye medications affect the eye's surface after cataract surgery. Cataract surgery patients often need to use eye drops to aid recovery, and these drops can contain preservatives like BAK, which might impact the health of the eye surface. The study includes 60 eyes, split into three groups, each receiving different formulations of eye drops. The aim is to determine the best concentration of BAK that maintains eye health while still being effective, potentially improving recovery for future patients undergoing cataract surgery. Participants will be divided into three groups, with each group receiving a different eye drop regimen. Group 1 will use Tobradex with a regular concentration of BAK, Group 2 will use Dexathalm with a lower concentration of BAK, and Group 3 will use a version of Dexathalm without BAK. The effectiveness and impact of these treatments will be evaluated by measuring tear stability and assessing symptoms of dry eye through a questionnaire. Assessments take place before surgery and at several points after surgery (day 1, one week, and three weeks) to compare results and determine which treatment is gentlest and most effective on the eye surface.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 40 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Patients undergoing uncomplicated cataract surgery * Cataract grade: (LOCSIII): NO2NC2,C3,P2 Exclusion Criteria: Preoperative non-invasive TBUT\<10 seconds. Patients who have rheumatoid arthritis or autoimmune diseases affecting corneal surface. Involutional entropion or ectropion preoperative Postoperative significant corneal edema requiring medication.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorGroup III
Active ComparatorStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location