NCT04204954

Evaluation of Treatment Option for Demodicosis in Patients Undergoing Cataract Surgery

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Hospital de La Luz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Demodex Infestation
• Demodicosis
• Cataract

Interventions

Type	Name	Description
OTHER	Tea Tree Oil Shampoo	Twice a day eyelid margin cleansing for three days.
DRUG	Ciprofloxacin Ophthalmic Ointment 0.3%	Applied topically in the eyelid margin every four hours for three days.
OTHER	Baby shampoo	Twice a day eyelid margin cleansing for three days.
OTHER	Blephaclean	Twice a day eyelid margin cleansing for three days.

Timeline

• Start date: 2019-05-06
• Primary completion: 2019-11-14
• Completion: 2019-12-13
• First posted: 2019-12-19
• Last updated: 2020-04-27

Locations

1 site across 1 country: Mexico

Regulatory

• FDA-regulated drug study