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Multicenter Clinical Trial for the Treatment of Dry Eye and Meibomian Gland Dysfunction whit iLUX

Evaluate the effect of heat application by light emission and compression under direct observation with the iLUX device for the treatment of Dry Eye and Meibomian Gland Dysfunction

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-2wbrh3t
Enrollment
Unknown
Registered
2022-07-08
Start date
2021-02-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blepharitis

Interventions

Eligible 96 patients, that fulfill the inclusion criteria for dry eye syndrome and blepharitis due to Meibomian gland disfunction. Patients will be divided in two groups: 48 patients treated with iLU

Sponsors

Clínica Oftalmológica Pereira Gomes
Lead Sponsor
Clínica Oftalmológica de Antioquia
Collaborator
Fundación Oftalmológica Los Andes
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age over 18 years; Patients who signed the consent form; Availability to attend all study visits; Positive history of dry eye symptoms prior to the study, using ocular surface disease index greater than or equal to 13 at patient's first visit; Evidence of Meibomian gland disfunction, diagnosed by a clinician not involved in the study and defined as a Meibomian gland secretion score less than 12 in 15 glands assessed in the lower eyelid; Non-invasive tear film break-up time (NIBUT) less than 10 seconds using the Keratograph 5M; Consent/ability to abstain from other dry eye/Meibomiun gland disfunction medications during the time between the screening visit and the end of the study;

Exclusion criteria

Exclusion criteria: Ocular surgery in the last 6 months; Cicatricial lid margin disease (symblepharon) identified by slit-lamp examination; Active ocular infection or active ocular inflammation or history of chronic, recurrent ocular inflammation within the prior 3 months; Treatment with LIpiFlow or Intense Pulsed Light Therapy in the previous 12 months; Treatment with omega-3; Use of topical cyclosporine; Use of topical steroids

Design outcomes

Primary

MeasureTime frame
To evaluate the effectiveness of iLUX treatment in patients with Meibomian gland dysfunction. We expect that the meibomian gland secretion scores increases from baseline measurements (4.0 more or less 3.4) to one month post-treatment

Secondary

MeasureTime frame
Increasing baseline tear break-up time (continuous measures) over the four assessments across the time of thirty days, evaluated by both invasive and non-invasive tear film break-up time. And improvement in ocular surface disease index symptom score (continuous measure) over four subsequent measures within one month.

Countries

Brazil, Chile, Colombia

Contacts

Public ContactJosé Alvaro;Felipe Gomes;Santana

Universidade Federal de São Paulo ;Fundación Oftalmológica Los Andes

japgomes13@gmail.com.br;felipevalenz@gmail.com+55(11) 5085-2082;+56 2 23704617

Outcome results

None listed

Source: REBEC (via WHO ICTRP)