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OpenTrials
Completed

NCT Number: NCT04204954

Evaluation of Treatment Option for Demodicosis in Patients Undergoing Cataract Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hospital de la Luz

Mexico City, 06030, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tea Tree Oil Shampoo

Other

Twice a day eyelid margin cleansing for three days.

Ciprofloxacin Ophthalmic Ointment 0.3%

Drug

Applied topically in the eyelid margin every four hours for three days.

Baby shampoo

Other

Twice a day eyelid margin cleansing for three days.

Other names: 50% diluted baby shampoo

Blephaclean

Other

Twice a day eyelid margin cleansing for three days.

Primary outcomes

  1. Mean Demodex spp. infestation index by intervention group

    Time frame: One week.

    Number of demodex (egg, larvae, nymph, adult-form) spp. per eyelash (taken from epilation).

  2. Crude count of Demodex spp. adult-forms (mites) in eyelashes by intervention group

    Time frame: One week.

    Number of demodex (egg, larvae, nymph, adult-form) spp. in total (taken from epilation).

Secondary outcomes

  1. Endophthalmitis in the postoperative period.

    Time frame: One week.

    Number of cases diagnosed with endophthalmitis in the postoperative period.

Sponsors and collaborators

Lead sponsor

Hospital de La Luz

Other

Collaborators

  • Andric C. Perez-Ortiz, M.D., M.P.H.
  • Azyadeh Camacho-Ordóñez, M.D., M.Sc.c.
  • Bani Antonio-Aguirre, M.D., M.P.H.c.
  • Claudia Palacio Pastrana, M.D., M.Sc.
  • Cristina Mendoza-Velasquez, M.D., M.Sc.
  • Hector Perez Cano, Ph.D.
  • Samuel J. Avalos Lara, M.D.

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 19, 2019
Registry last updated
Apr 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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