Evaluation of Treatment Option for Demodicosis in Patients Undergoing Cataract Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-06

Study Completion Date

2019-12-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Topical Besifloxacin on Ocular Surface Bacterial Microbiota Prior to Cataract Surgery

NCT04542759

Microbial Disease Cataract Senile

COMPLETED PHASE1

Comparison of the Effectiveness of Povidone-iodine in Reducing Conjunctival Bacterial Load Prior to Cataract Surgery in Patients Treated With a Lidocaine Gel Dilating Formulation Versus Eye Drops: A Randomized Controlled Trial

NCT01898728

Cataracts

COMPLETED NA

Effect of Intraoperative Dexamethasone on Post-op Dry Eye

NCT04184999

Dry Eye Syndromes

COMPLETED PHASE4

A Clinical Study to Assess the Efficacy and Safety of Dexamethasone Suspension for Cataract Surgery

NCT03687931

Inflammation Eye

COMPLETED PHASE1/PHASE2

Prophylaxis Prior to Cataract Surgery Conjunctival Flora and Optimal Ocular Sterilization Technique Prior to Cataract Surgery

NCT00406913

Endophthalmitis Cataract Surgery Prophylaxis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Demodex Infestation Demodicosis Cataract

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1: Topical 0.3% Ciprofloxacin [Cipro]

Ciprofloxacin Ophthalmic Ointment 0.3% every four hours for three days.

Group Type OTHER

Ciprofloxacin Ophthalmic Ointment 0.3%

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Ciprofloxacin Ophthalmic Ointment 0.3%

Intervention Type DRUG

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

Baby shampoo

Intervention Type OTHER

Twice a day eyelid margin cleansing for three days.

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.

Group Type ACTIVE_COMPARATOR

Ciprofloxacin Ophthalmic Ointment 0.3%

Intervention Type DRUG

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

Blephaclean

Intervention Type OTHER

Twice a day eyelid margin cleansing for three days.

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.

Group Type EXPERIMENTAL

Tea Tree Oil Shampoo

Intervention Type OTHER

Twice a day eyelid margin cleansing for three days.

Ciprofloxacin Ophthalmic Ointment 0.3%

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tea Tree Oil Shampoo

Twice a day eyelid margin cleansing for three days.

Intervention Type OTHER

Ciprofloxacin Ophthalmic Ointment 0.3%

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

Intervention Type DRUG

Baby shampoo

Twice a day eyelid margin cleansing for three days.

Intervention Type OTHER

Blephaclean

Twice a day eyelid margin cleansing for three days.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

50% diluted baby shampoo

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.