Clinical trial NCT04204954: Evaluation of Treatment Option for Demodicosis in Patients Undergoing Cataract Surgery
Official title: A Randomized Controlled Trial of Treatment Efficacy in Ameliorating Demodex Spp. Infestation Among Cases Undergoing Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Demodex Infestation
Demodicosis
Cataract
Lead sponsor: Hospital de La Luz
Sponsor class: OTHER
Collaborators: name: Claudia Palacio Pastrana, M.D., M.Sc.
name: Samuel J. Avalos Lara, M.D.
name: Hector Perez Cano, Ph.D.
name: Bani Antonio-Aguirre, M.D., M.P.H.c.
name: Cristina Mendoza-Velasquez, M.D., M.Sc.
name: Azyadeh Camacho-Ordóñez, M.D., M.Sc.c.
name: Andric C. Perez-Ortiz, M.D., M.P.H.
First posted: 2019-12-19
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients diagnosed with Demodex spp. infestation undergoing cataract surgery were randomly allocated into four comparison groups a control group (standard treatment) and three new modalities of Demodex therapy (Blephaclean, baby shampoo, and tea tree oil) + conventional treatment.
Primary purpose: TREATMENT

Brief summary: Demodex blepharitis is a prevalent cause of comorbid infection among individuals undergoing cataract surgery. Several complications may arise in the postsurgical period from Staphylococcus or Streptococcus co-infections, as Demodex is a vector for these pathogens. Hence, prophylactic treatments before cataract surgery may lead to a reduction in complication rates. Since Demodex infestation and cataract surgery are two prevalent coexisting conditions in the general population, this study aims to test the effect of four combined treatments to eradicate or improve the Demodex infestation index before surgery. The investigators are conducting a single-blinded randomized trial of four therapies in participants undergoing cataract surgery. All participants will or are receiving daily eyelid cleansing bid and topical 0.3% ciprofloxacin q4h for three days added to the allocated treatment arm. Our four intervention groups are: \[1\] Blephaclean eye scrubs; \[2\] 50% dilution baby shampoo; \[3\] tea tree oil shampoo; \[4\]: topical 0.3% ciprofloxacin alone. To assess treatment efficacy, the investigators will perform eyelash hair epilation pre and postoperatively. The primary outcome is a change in the mean Demodex spp. infestation index. Also, a change in the crude number of Demodex (egg, larvae, nymph, or adult-form) spp. in eyelashes after one-week of therapy.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent after explanation of the nature and possible consequences of the study.
* Clinical diagnosis of cataracts staged with Lens Opacity Classification System III based on the American Academy of Ophthalmology and the American Society of Cataract and Refractive Surgery guidelines.
* No topical antibiotic ointment therapy or eyelid cleansing in the past six months.
* No systemic antibiotic or antiparasite treatment in the past six months.
* No ocular comorbidities (other than cataracts)
* No systemic comorbidities.

Exclusion Criteria:

* Withdrawal from the study.
* Minimal changes based on the Lens Opacity Classification System III.

Primary outcomes:
measure: Mean Demodex spp. infestation index by intervention group
timeFrame: One week.
measure: Crude count of Demodex spp. adult-forms (mites) in eyelashes by intervention group
timeFrame: One week.
Secondary outcomes:
measure: Endophthalmitis in the postoperative period.
timeFrame: One week.
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Hospital de la Luz
Study officials:
affiliation: Hospital de La Luz
name: Claudia Palacio Pastrana, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References: