Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Claudia Palacio Pastrana, M.D., M.Sc. | UNKNOWN |
| Samuel J. Avalos Lara, M.D. | UNKNOWN |
| Hector Perez Cano, Ph.D. | UNKNOWN |
| Bani Antonio-Aguirre, M.D., M.P.H.c. |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Topical 0.3% Ciprofloxacin [Cipro] | Other | Ciprofloxacin Ophthalmic Ointment 0.3% every four hours for three days. |
|
| Group 2: Cipro + 50% diluted baby shampoo | Active Comparator | 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 3: Cipro + Blephaclean | Active Comparator | 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 4: Cipro + Tea tree oil. | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tea Tree Oil Shampoo | Other | Twice a day eyelid margin cleansing for three days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Demodex spp. infestation index by intervention group | Number of demodex (egg, larvae, nymph, adult-form) spp. per eyelash (taken from epilation). | One week. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Endophthalmitis in the postoperative period. | Number of cases diagnosed with endophthalmitis in the postoperative period. | One week. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Claudia Palacio Pastrana, M.D., M.P.H. | Hospital de La Luz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de la Luz | Mexico City | 06030 | Mexico |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| UNKNOWN |
| Cristina Mendoza-Velasquez, M.D., M.Sc. | UNKNOWN |
| Azyadeh Camacho-Ordóñez, M.D., M.Sc.c. | UNKNOWN |
| Andric C. Perez-Ortiz, M.D., M.P.H. | UNKNOWN |
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.
Not provided
Not provided
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.
| Ciprofloxacin Ophthalmic Ointment 0.3% | Drug | Applied topically in the eyelid margin every four hours for three days. |
|
| Baby shampoo | Other | Twice a day eyelid margin cleansing for three days. |
|
|
| Blephaclean | Other | Twice a day eyelid margin cleansing for three days. |
|