Clinical trial NCT02825186: Dexamethasone (Sterodex) Versus Loteprendol (Lotemax) Eye Drops Following Strabismus Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ophthalmology
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-07-07
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy and side effects of topical Loteprendol etabonate 0.5% (Lotemax) versus Dexamethasone 0.1% (Sterodex) following strabismus surgery.

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:

1. Patient pain and discomfort
2. Conjunctival chemosis
3. Conjunctival hyperaemia
4. Conjunctival discharge
5. Conjunctival gap
6. Intraocular pressure (IOP)
7. Number of pain control medications taken

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline - Intraocular pressure (IOP)
timeFrame: 1 day before surgery (basline), and 1 day, 1 week, 2 weeks, 4 weeks after surgery
measure: Change from baseline - Conjunctival hyperemia
timeFrame: 1 day before surgery (basline), and 1 day, 1 week, 2 weeks, 4 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Department of Ophthalmology, Tel Aviv Sourasky Medical Center
Study officials:
References: