Demodex Infestation, Demodicosis, Cataract
Conditions
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.
Interventions
OTHERTea Tree Oil Shampoo
Twice a day eyelid margin cleansing for three days.
DRUGCiprofloxacin Ophthalmic Ointment 0.3%
Applied topically in the eyelid margin every four hours for three days.
OTHERBaby shampoo
Twice a day eyelid margin cleansing for three days.
OTHERBlephaclean
Twice a day eyelid margin cleansing for three days.
Sponsors
Claudia Palacio Pastrana, M.D., M.Sc.
Samuel J. Avalos Lara, M.D.
Hector Perez Cano, Ph.D.
Bani Antonio-Aguirre, M.D., M.P.H.c.
Cristina Mendoza-Velasquez, M.D., M.Sc.
Azyadeh Camacho-Ordóñez, M.D., M.Sc.c.
Andric C. Perez-Ortiz, M.D., M.P.H.
Hospital de La Luz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Investigators and outcomes assessors were blinded to the treatment allocation of each participant. Outcome assessors were anterior segment surgeons who evaluated cases prior to cataract surgery. There was no indication of group allocation in the electronic medical records (EMR), only the participation of each candidate in the study. Similarly, investigators were blinded to group allocation and only recorded data directly from EMR. Blinding was kept after data analysis.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Demodex spp. infestation index by intervention group | One week. | Number of demodex (egg, larvae, nymph, adult-form) spp. per eyelash (taken from epilation). |
| Crude count of Demodex spp. adult-forms (mites) in eyelashes by intervention group | One week. | Number of demodex (egg, larvae, nymph, adult-form) spp. in total (taken from epilation). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endophthalmitis in the postoperative period. | One week. | Number of cases diagnosed with endophthalmitis in the postoperative period. |
Countries
Mexico
Outcome results
None listed