Evaluation of Treatment Option for Demodicosis in Patients Undergoing Cataract Surgery

Phase 2

Completed

• Conditions: Demodex Infestation; Demodicosis; Cataract
• Interventions: Drug: Ciprofloxacin Ophthalmic Ointment 0.3%; Other: Tea Tree Oil Shampoo; Other: Baby shampoo; Other: Blephaclean

• Registration Number: NCT04204954
• Lead Sponsor: Hospital de La Luz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-06
• Primary Completion: 2019-11-14
• Study Completion: 2019-12-13
• Study First Submitted: 2019-12-14
• Study First Submitted QC: 2019-12-17
• Study First Posted: 2019-12-19
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-23
• Last Update Posted: 2020-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 3: Cipro + Blephaclean	Ciprofloxacin Ophthalmic Ointment 0.3%	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.
Group 1: Topical 0.3% Ciprofloxacin [Cipro]	Ciprofloxacin Ophthalmic Ointment 0.3%	Ciprofloxacin Ophthalmic Ointment 0.3% every four hours for three days.
Group 4: Cipro + Tea tree oil.	Tea Tree Oil Shampoo	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.
Group 4: Cipro + Tea tree oil.	Ciprofloxacin Ophthalmic Ointment 0.3%	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.
Group 2: Cipro + 50% diluted baby shampoo	Baby shampoo	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.
Group 2: Cipro + 50% diluted baby shampoo	Ciprofloxacin Ophthalmic Ointment 0.3%	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.
Group 3: Cipro + Blephaclean	Blephaclean	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Endophthalmitis in the postoperative period.	One week.	Number of cases diagnosed with endophthalmitis in the postoperative period.

Trial Locations

Locations (1)

Hospital de la Luz; 🇲🇽 Mexico City, Mexico