Evaluation of Treatment Option for Demodicosis in Patients Undergoing Cataract Surgery

Hospital de La Luz

Status and phase: Completed; Phase 3; Phase 2

Conditions: Cataract; Demodex Infestation; Demodicosis

Treatments: Drug: Ciprofloxacin Ophthalmic Ointment 0.3%; Other: Baby shampoo; Other: Blephaclean; Other: Tea Tree Oil Shampoo

Study type: Interventional

Funder types: Other

Identifiers

NCT04204954

201959B1

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 4 patient groups

Group 1: Topical 0.3% Ciprofloxacin [Cipro]

Other group

Description:

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

Treatment:

Drug: Ciprofloxacin Ophthalmic Ointment 0.3%

Group 2: Cipro + 50% diluted baby shampoo

Active Comparator group

Description:

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.

Treatment:

Other: Baby shampoo

Drug: Ciprofloxacin Ophthalmic Ointment 0.3%

Group 3: Cipro + Blephaclean

Active Comparator group

Description:

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.

Treatment:

Other: Blephaclean

Drug: Ciprofloxacin Ophthalmic Ointment 0.3%

Group 4: Cipro + Tea tree oil.

Experimental group

Description:

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.

Treatment:

Other: Tea Tree Oil Shampoo

Drug: Ciprofloxacin Ophthalmic Ointment 0.3%