- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02825186
Dexamethasone (Sterodex) Versus Loteprendol (Lotemax) Eye Drops Following Strabismus Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a randomized prospective study that will involve 100 patients (males and females) undergoing strabismus surgery. All patients will be randomly assigned to receive one of the study drugs (Loteprendol etabonate 0.5% (Lotemax) drops or Dexamethasone 0.1% (Sterodex) drops) after undergoing strabismus surgery. In addition to the study drug all patients (in both groups) will receive topical Ofloxacin 0.3% (Oflox) eye drops. All patients will undergo a complete ophthalmological evaluation before surgery including orthoptic assessment of their strabismus and measurement of intraocular pressure (IOP). Topical treatment with the study drug and topical Ofloxacin 0.3% (Oflox) eye drops will begin on the evening of the surgery, following a schedule that will be the same for both groups: 4 times daily during the first week, 3 times daily for the second group, twice daily for the third week, and as needed for the fourth week. All patients will be examined at 1 day, 1 week, 2 weeks and 4 weeks after surgery by a masked investigator (not the strabismus surgeon).
The parameters to be checked will include:
- Patient pain and discomfort
- Conjunctival chemosis
- Conjunctival hyperaemia
- Conjunctival discharge
- Conjunctival gap
- Intraocular pressure (IOP)
- Number of pain control medications taken
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Tel Aviv, Israel, 64239
- Department of Ophthalmology, Tel Aviv Sourasky Medical Center
-
Contact:
- Gad Dotan, MD
- Phone Number: 972-3-6974165
- Email: gadd@tlvmc.gov.il
-
Contact:
- Keren Elia Ogalbo
- Phone Number: 972-3-6974165
- Email: kernel@tlvmc.gov.il
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients undergoing recession strabismus surgery through a fornix approach of one of the horizontal recti muscles (either medial rectus or lateral rectus) or of the inferior oblique muscle
- Must be able to comply with topical treatment
- Must be able to comply with post-operative appointment schedule.
Exclusion criteria:
- Previous ocular surgery (including previous strabismus surgery)
- Ocular pathology
- Family history of glaucoma
- Personal history of allergic drug reaction or allergic conjunctivitis
- More than one muscle operated on
- Adjustable sutures technique
- Patients in whom it is impossible to measure IOP before surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Loteprendol
Topical Loteprendol used after strabismus surgery
|
Steroid eye drops used after strabismus surgery.
|
Experimental: Dexamethasone
Topical Dexamethasone used after strabismus surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline - Intraocular pressure (IOP)
Time Frame: 1 day before surgery (basline), and 1 day, 1 week, 2 weeks, 4 weeks after surgery
|
IOP will be measured by Goldmann applantation tonometry one day before surgery (baseline IOP).
In patients in whom Goldmann tonometry is impossible, ICARE tonometer will be used instead.
IOP will be measured 1 day, 1 week, 2 weeks, 4 weeks after surgery, at each time point change from baseline IOP will be recorded.
|
1 day before surgery (basline), and 1 day, 1 week, 2 weeks, 4 weeks after surgery
|
Change from baseline - Conjunctival hyperemia
Time Frame: 1 day before surgery (basline), and 1 day, 1 week, 2 weeks, 4 weeks after surgery
|
Conjunctival hyepremia will be measured one day before surgery (basline measurement) using the following scale: 0=no hyperemia, 1=mild (less than one quadrant), 2=moderate (less than half of the conjunctival surface), 3= severe (less than half of the conjunctival surface).
Conjunctival hyperemia will be measured 1 day, 1 week, 2 weeks, 4 weeks after surgery, at each time point change from baseline measurement will be recorded.
|
1 day before surgery (basline), and 1 day, 1 week, 2 weeks, 4 weeks after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TLV-015-0185
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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