Hospital de la Luz
Mexico City, 06030, Mexico
NCT Number: NCT04204954
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 2 / Phase 3
Mexico City, 06030, Mexico
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Twice a day eyelid margin cleansing for three days.
Applied topically in the eyelid margin every four hours for three days.
Twice a day eyelid margin cleansing for three days.
Other names: 50% diluted baby shampoo
Twice a day eyelid margin cleansing for three days.
Time frame: One week.
Number of demodex (egg, larvae, nymph, adult-form) spp. per eyelash (taken from epilation).
Time frame: One week.
Number of demodex (egg, larvae, nymph, adult-form) spp. in total (taken from epilation).
Time frame: One week.
Number of cases diagnosed with endophthalmitis in the postoperative period.
Hospital de La Luz
Other
A Randomized Controlled Trial of Treatment Efficacy in Ameliorating Demodex Spp. Infestation Among Cases Undergoing Cataract Surgery
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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