Acne Vulgaris, Dry Eye Disease (DED), Meibomian Gland Dysfunction (Disorder)
Conditions
Keywords
dry eye, isotretinoin, acne, Meibomian gland
Brief summary
The aim of the study was to evaluate meibomian gland morphology using non-contact meibography and ocular surface changes in patients with acne vulgaris treated with isotretinoin as indicators of dry eye, which is known to be a side effect of isotretinoin.
Detailed description
Purpose: This study investigated the effects of oral isotretinoin treatment for acne vulgaris on the ocular surface and meibomian gland morphology. Isotretinoin, a common and effective acne medication, is known to cause dry eye symptoms, but its specific impact on ocular surface parameters and meibomian glands requires further detailed assessment. Study Design: This was a prospective, non-randomized, controlled study involving 60 participants. Thirty patients with moderate to severe acne vulgaris, who were candidates for oral isotretinoin therapy, were recruited as the case group. A control group of 30 age- and gender-matched healthy individuals without acne vulgaris was also included. The case group received low-dose oral isotretinoin (0.1-0.4 mg/kg/day) for 6 months, while the control group received no intervention. Outcome Measures: Primary outcome measures included changes in Meibomian gland Morphology (assessed by Meiboscore via non-contact meibography) and Ocular Surface Disease Index (OSDI) scores. Secondary outcome measures included changes in Invasive Tear Film Break-Up Time (ITF-BUT), Schirmer II test results, Ocular Surface Staining (Oxford Scale), Meibum Expressibility Score (MES), Eyelid Score, and Non-Invasive Tear Film Break-Up Time (NIF-BUT). All ocular parameters were assessed at baseline and after 6 months of treatment in the case group and at baseline in the control group.
Interventions
DRUGisotretinoin
1. Meibomian Gland Morphology (Meiboscore) 2. Ocular Surface Disease Index (OSDI) Score 3. Invasive Tear Film Break-Up Time (ITF-BUT) 4. Schirmer II Test 5. Ocular Surface Staining (Oxford Scale) 6. Meibum Expressibility Score (MES) 7. Eyelid Score 8. Non-Invasive Tear Film Break-Up Time (NIF-BUT) time frame: at baseline and 6 months after isotretinoin therapy
Sponsors
Benha University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Patients with clinically diagnosed acne vulgaris with various degrees of severity candidates for oral isotretinoin treatment. * Moderate to advanced stage of acne vulgaris. * No significant improvement with local and systemic antibiotic therapy. * Normal liver transaminase (AST, ALT) and lipid (Cholesterol, TG) levels
Exclusion criteria
* Patients with only comedonal acne. * Prior use of systemic isotretinoin. * Contact lens wearers. * History of ocular trauma or surgery (within 1 year). * Other systemic or dermatologic diseases. * Active conjunctivitis or allergy. * Use of medications affecting the ocular surface or meibomian glands. Lid deformity or abnormal lid movement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1 Meibomian Gland Morphology (Meiboscore) | Baseline and 6 months | Change in Meibomian Gland dropout area semi-automatically calculated by percentage and graded as Meiboscore: Grade 0 (no loss), Grade 1 (≤25%), Grade 2 (26-50%), Grade 3 (51-75%), and Grade 4 (\>75%). |
| 2 Ocular Surface Disease Index (OSDI) Score | Baseline and 6 months. | Change in the OSDI questionnaire score (0-100) to assess subjective ocular surface symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Invasive Tear Film Break-Up Time (ITF-BUT) | Baseline and 6 months. | Change in tear film stability measured in seconds after fluorescein instillation. |
| Schirmer II Test | Baseline and 6 months | Change in basal tear film production measured in millimeters (mm) with anesthesia. |
| 5 Ocular Surface Staining (Oxford Scale) | Baseline and 6 months. | Change in corneal and conjunctival staining evaluated using the Oxford grading schema (Score 0-15). |
| 6 Meibum Expressibility Score (MES) | Baseline and 6 months. | Change in meibum expressibility graded from 0 (all glands expressible) to 3 (no glands expressible). |
| 7 Eyelid Score | Baseline and 6 months. | Change in eyelid margin signs (telangiectasia, irregularity, obstructed orifices, junction displacement) scored from 0 to 4. |
| 8 Non-Invasive Tear Film Break-Up Time (NIF-BUT) | Baseline and 6 months | Change in tear film stability measured non-invasively using the Sirius device. |
Countries
Egypt
Outcome results
None listed