Evaluation of Treatment Option for Demodicosis in Patients Undergoing Cataract Surgery

Last updated: April 23, 2020
Sponsor: Hospital de La Luz
Overall Status: Completed

Phase

2/3

Condition

Eye Disorders/infections

Vision Loss

Eye Disease

Treatment

N/A

Clinical Study ID

NCT04204954
201959B1
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Signed informed consent after explanation of the nature and possible consequences ofthe study.

  • Clinical diagnosis of cataracts staged with Lens Opacity Classification System IIIbased on the American Academy of Ophthalmology and the American Society of Cataractand 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

Exclusion Criteria:

  • Withdrawal from the study.

  • Minimal changes based on the Lens Opacity Classification System III.

Study Design

Total Participants: 160
Study Start date:
May 06, 2019
Estimated Completion Date:
December 13, 2019

Connect with a study center

  • Hospital de la Luz

    Mexico City, 06030
    Mexico

    Site Not Available

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