Evaluation of Treatment Option for Demodicosis in Patients Undergoing Cataract Surgery

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

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.

Sponsors & Collaborators

• Claudia Palacio Pastrana, M.D., M.Sc.

  collaborator UNKNOWN

• Samuel J. Avalos Lara, M.D.

  collaborator UNKNOWN

• Hector Perez Cano, Ph.D.

  collaborator UNKNOWN

• Bani Antonio-Aguirre, M.D., M.P.H.c.

  collaborator UNKNOWN

• Cristina Mendoza-Velasquez, M.D., M.Sc.

  collaborator UNKNOWN

• Azyadeh Camacho-Ordóñez, M.D., M.Sc.c.

  collaborator UNKNOWN

• Andric C. Perez-Ortiz, M.D., M.P.H.

  collaborator UNKNOWN

• Hospital de La Luz

  lead OTHER

Principal Investigators

• Claudia Palacio Pastrana, M.D., M.P.H. · Hospital de La Luz

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-05-06

Primary Completion

2019-11-14

Completion

2019-12-13

FDA Drug

Yes

Countries

• Mexico

Study Locations