Evaluation of Treatment Option for Demodicosis in Patients Undergoing Cataract Surgery

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04204954
• Other study ID #: 201959B1
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 6, 2019
• Est. completion date: December 13, 2019

Study information

• Verified date: April 2020
• Source: Hospital de La Luz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 13, 2019
• Est. primary completion date: November 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Demodex Infestation
• Demodicosis
• Parasitic Diseases

Intervention

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.
• Blephaclean
Twice a day eyelid margin cleansing for three days.

Locations

Country	Name	City	State
Mexico	Hospital de la Luz	Mexico City

Sponsors (8)

Lead Sponsor	Collaborator
Hospital de La Luz	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.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Demodex spp. infestation index by intervention group	Number of demodex (egg, larvae, nymph, adult-form) spp. per eyelash (taken from epilation).	One week.
Primary	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	Endophthalmitis in the postoperative period.	Number of cases diagnosed with endophthalmitis in the postoperative period.	One week.