Dexamethasone (Sterodex) Versus Loteprendol (Lotemax) Eye Drops Following Strabismus Surgery

Tel Aviv Sourasky Medical Center

Status: Unknown

Conditions: Ophthalmology

Treatments: Drug: Dexamethasone 0.1%; Drug: Loteprendol etabonate 0.5%

Study type: Interventional

Funder types: Other

Identifiers

NCT02825186

TLV-015-0185

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Loteprendol

Experimental group

Description:

Topical Loteprendol used after strabismus surgery

Treatment:

Drug: Loteprendol etabonate 0.5%

Dexamethasone

Experimental group

Description:

Topical Dexamethasone used after strabismus surgery

Treatment:

Drug: Dexamethasone 0.1%