Evaluation of Treatment Option for Demodicosis in Patients Undergoing Cataract Surgery

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Trial of Treatment Efficacy in Ameliorating Demodex Spp. Infestation Among Cases Undergoing Cataract Surgery

Conditions
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Demodex Infestation, Demodicosis, Cataract

Intervention / Treatment
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* Other: Tea Tree Oil Shampoo
* Drug: Ciprofloxacin Ophthalmic Ointment 0.3%
* Other: Baby shampoo
* Other: Blephaclean


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1: Topical 0.3% Ciprofloxacin [Cipro]<br>Ciprofloxacin Ophthalmic Ointment 0.3% every four hours for three days. | Drug: Ciprofloxacin Ophthalmic Ointment 0.3%<br>* Applied topically in the eyelid margin every four hours for three days.<br>|
| Active Comparator: Group 2: Cipro + 50% diluted baby shampoo<br>Ciprofloxacin Ophthalmic Ointment 0.3% every four hours for three days. Twice a day eyelid margin cleansing with 50% diluted baby shampoo for three days. | Drug: Ciprofloxacin Ophthalmic Ointment 0.3%<br>* Applied topically in the eyelid margin every four hours for three days.<br>Other: Baby shampoo<br>* Twice a day eyelid margin cleansing for three days.<br>* Other names: 50% diluted baby shampoo;|
| Active Comparator: Group 3: Cipro + Blephaclean<br>Ciprofloxacin Ophthalmic Ointment 0.3% every four hours for three days. Twice a day eyelid margin cleansing with Blephaclean Sterile Eyelid Wipes (Thea Pharmaceuticals) for three days. | Drug: Ciprofloxacin Ophthalmic Ointment 0.3%<br>* Applied topically in the eyelid margin every four hours for three days.<br>Other: Blephaclean<br>* Twice a day eyelid margin cleansing for three days.<br>|
| Experimental: Group 4: Cipro + Tea tree oil.<br>Ciprofloxacin Ophthalmic Ointment 0.3% every four hours for three days. Twice a day eyelid margin cleansing with tea tree oil shampoo for three days. | Other: Tea Tree Oil Shampoo<br>* Twice a day eyelid margin cleansing for three days.<br>Drug: Ciprofloxacin Ophthalmic Ointment 0.3%<br>* Applied topically in the eyelid margin every four hours for three days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Demodex spp. infestation index by intervention group | Number of demodex (egg, larvae, nymph, adult-form) spp. per eyelash (taken from epilation). | One week. | 
| Crude count of Demodex spp. adult-forms (mites) in eyelashes by intervention group | Number of demodex (egg, larvae, nymph, adult-form) spp. in total (taken from epilation). | One week. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endophthalmitis in the postoperative period. | Number of cases diagnosed with endophthalmitis in the postoperative period. | One week. |