Evaluation of Treatment Option for Demodicosis in Patients Undergoing Cataract Surgery

Sponsor

Hospital de La Luz (Other)

Overall Status

Completed

CT.gov ID

NCT04204954

Collaborator

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

160

Enrollment

Location

Arms

7.3

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Demodex Infestation Demodicosis Cataract	Other: Tea Tree Oil Shampoo Drug: Ciprofloxacin Ophthalmic Ointment 0.3% Other: Baby shampoo Other: Blephaclean	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients diagnosed with Demodex spp. infestation undergoing cataract surgery were randomly allocated into four comparison groups a control group (standard treatment) and three new modalities of Demodex therapy (Blephaclean, baby shampoo, and tea tree oil) + conventional treatment.Patients diagnosed with Demodex spp. infestation undergoing cataract surgery were randomly allocated into four comparison groups a control group (standard treatment) and three new modalities of Demodex therapy (Blephaclean, baby shampoo, and tea tree oil) + conventional treatment.

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

Investigators and outcomes assessors were blinded to the treatment allocation of each participant. Outcome assessors were anterior segment surgeons who evaluated cases prior to cataract surgery. There was no indication of group allocation in the electronic medical records (EMR), only the participation of each candidate in the study. Similarly, investigators were blinded to group allocation and only recorded data directly from EMR. Blinding was kept after data analysis.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 6, 2019

Actual Primary Completion Date :

Nov 14, 2019

Actual Study Completion Date :

Dec 13, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Group 1: Topical 0.3% Ciprofloxacin [Cipro] Ciprofloxacin Ophthalmic Ointment 0.3% every four hours for three days.	Drug: Ciprofloxacin Ophthalmic Ointment 0.3% Applied topically in the eyelid margin every four hours for three days.
Active Comparator: Group 2: Cipro + 50% diluted baby shampoo Ciprofloxacin Ophthalmic Ointment 0.3% every four hours for three days. Twice a day eyelid margin cleansing with 50% diluted baby shampoo 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 Names: 50% diluted baby shampoo
Active Comparator: Group 3: Cipro + Blephaclean Ciprofloxacin Ophthalmic Ointment 0.3% every four hours for three days. Twice a day eyelid margin cleansing with Blephaclean Sterile Eyelid Wipes (Thea Pharmaceuticals) for three days.	Drug: Ciprofloxacin Ophthalmic Ointment 0.3% Applied topically in the eyelid margin every four hours for three days. Other: Blephaclean Twice a day eyelid margin cleansing for three days.
Experimental: Group 4: Cipro + Tea tree oil. Ciprofloxacin Ophthalmic Ointment 0.3% every four hours for three days. Twice a day eyelid margin cleansing with tea tree oil shampoo for three days.	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.

Outcome Measures

Primary Outcome Measures

Mean Demodex spp. infestation index by intervention group [One week.]
Number of demodex (egg, larvae, nymph, adult-form) spp. per eyelash (taken from epilation).
Crude count of Demodex spp. adult-forms (mites) in eyelashes by intervention group [One week.]
Number of demodex (egg, larvae, nymph, adult-form) spp. in total (taken from epilation).

Secondary Outcome Measures

Endophthalmitis in the postoperative period. [One week.]
Number of cases diagnosed with endophthalmitis in the postoperative period.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital de la Luz	Mexico City		Mexico	06030

Investigators

Principal Investigator: Claudia Palacio Pastrana, M.D., M.P.H., Hospital de La Luz

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Andric C Perez-Ortiz, M.D., M.P.H., Clinical Professor, Hospital de La Luz

ClinicalTrials.gov Identifier:

NCT04204954

Other Study ID Numbers:

201959B1

First Posted:

Dec 19, 2019

Last Update Posted:

Apr 27, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2020