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NCT06404541 Clinical Trial

A Comparative Study Between Preservative With Benzalkonium Chloride vs Preservative Free Eye Drops on the Ocular Surface

Dry Eye Syndromes Clinical Trial

Official title:
A Comparison Between the Ocular Surface of Different Concentrations of Benzalkonium Chloride Preservative in Postoperative Topical Medications After Cataract Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06404541
Other study ID # MS-127-2023
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date January 10, 2024
Est. completion date May 2024

Study information
Verified date May 2024
Source Kasr El Aini Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

study the effect of different concentrations of benzalkonium chloride on the ocular surface of non-dry-eyed patients post cataract surgery.

Description:

60 eyes of will be included in this study. - 20 eyes will receive regular Tobradex 0.1mg/ml BAK 5 times per day (Group 1). - 20 eyes will receive Dexathalm multidose 0.05mg/ml BAK 5 times per day (Group 2). - 20 eyes will receive single dose unit Dexathalm NO BAK 5 times per day (Group 3). Preoperative assessment: All selected patients will receive thorough explanation of the study design and aims, an informed consent will be obtained from all patients. Tear break up time (TBUT) will be measured non-invasively by Ocular Surface analyzer. Ocular Surface disease index will be calculated by filling a questionnaire. 12-item questionnaire provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning. Postoperative: 1. All patients will be examined at day1, 1 week and 3 week postoperative. 2. At 3 weeks re-evaluate I. TBUT by non-invasive ocular surface analyzer II. OSDI by filling the questionnaire.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 60
Est. completion date May 2024
Est. primary completion date April 10, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 70 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dexamethasone, tobramycin, netilimicin
Group A: Dexathalm single dose Group B: Tobradex Group C: Dexathalm multi-dose

Locations
Country Name City State
Egypt KasrAl Ainy Hospital Cairo Giza

Sponsors (1)
Lead Sponsor Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary NBUT non invasive tear break up time preoperative and 1 month postoperative
Primary TMH Tear meniscus Height preoperative and 1 month postoperative
Primary OSDI ocular surface disease index preoperative and 1 month postoperative
Primary MG loss meibomian gland loss preoperative and 1 month postoperative
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