A Study of the Effect of Different Doses of Difluprednate Eye Drops on the Intraocular Pressure After Phacoemulsification
NCT ID: NCT05649111
Last Updated: 2022-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
20 participants
INTERVENTIONAL
2022-11-01
2023-02-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
IVI Aflibercept Before and After Phaco in DME.
NCT05731089
Difluprednate vs. a Prednisolone Acetate - Phenylephrine on Post-operative Inflammation Following Cataract Surgery.
NCT04631315
Effect of Nepafenac on Post-operative Macular Swelling Following Uncomplicated Cataract Surgery
NCT00494494
Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis
NCT00405496
Effect of Lipid Lowering Agents on Diabetic Retinopathy and Cardiovascular Risk of Diabetic Patients
NCT04140201
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
All cases will receive Nepafenac 0.1% ( Nevanac 0.1%) 3 times per day on the last preoperative day, one tablet of Acetazolamide 250 mg (Cidamex 250mg) within the first 3 hours after the procedure and Moxifloxacin (Vigamox 0.5%) 0.1 ml intracameral and post-operative drops 3 times per day for 10 days and will be divided into:
In this pilot study:
* Group A : will receive Difluprednate 4 times per day for 1 week, then twice per day for 1 week and then once per day for 5 days starting 24 hours after the operation
* Group B : will receive Difluprednate 3 times per day for 4 days, then twice per day for 4 days and then once per day for 4 days starting 4 hours after the operation
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
* Group B will receive Difluprednate 3 times per day for 4 days, then twice per day for 4 days and then once per day for 4 days starting 4 hours after the operation
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A
will receive Difluprednate 4 times per day for 1 week, then twice per day for 1 week and then once per day for 5 days starting 24 hours after the operation
Difluprednate Eye Drops
post-operative cataract surgery medication regimen. but different dosages between the 2 groups.
Group B
will receive Difluprednate 3 times per day for 4 days, then twice per day for 4 days and then once per day for 4 days starting 4 hours after the operation
Difluprednate Eye Drops
post-operative cataract surgery medication regimen. but different dosages between the 2 groups.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Difluprednate Eye Drops
post-operative cataract surgery medication regimen. but different dosages between the 2 groups.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Grade 1 to 4 nuclear cataract LOCS II
* Cumulative dissipated energy CDE 1 to 10
* Done by a single surgeon using the chopping technique
Exclusion Criteria
* the use of topical or systemic steroids on the last post-operative day
* Intraoperative or postoperative complications
* Intraoperative iris manipulations or phaco traume
40 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kafrelsheikh University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ahmed Hashiem
Lecturer of ophthalmology ,ophthalmology consultant
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ahmed Hashem, PhD
Role: PRINCIPAL_INVESTIGATOR
Kafrelsheikh university faculty of medicin
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kafrelsheikh University
Kafr ash Shaykh, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
50-11-16
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.