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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
60
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
faculty of Medicine
Banhā, Egypt
1 Meibomian Gland Morphology (Meiboscore)
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%).
Time frame: Baseline and 6 months
2 Ocular Surface Disease Index (OSDI) Score
Change in the OSDI questionnaire score (0-100) to assess subjective ocular surface symptoms.
Time frame: Baseline and 6 months.
Invasive Tear Film Break-Up Time (ITF-BUT)
Change in tear film stability measured in seconds after fluorescein instillation.
Time frame: Baseline and 6 months.
Schirmer II Test
Change in basal tear film production measured in millimeters (mm) with anesthesia.
Time frame: Baseline and 6 months
5 Ocular Surface Staining (Oxford Scale)
Change in corneal and conjunctival staining evaluated using the Oxford grading schema (Score 0-15).
Time frame: Baseline and 6 months.
6 Meibum Expressibility Score (MES)
Change in meibum expressibility graded from 0 (all glands expressible) to 3 (no glands expressible).
Time frame: Baseline and 6 months.
7 Eyelid Score
Change in eyelid margin signs (telangiectasia, irregularity, obstructed orifices, junction displacement) scored from 0 to 4.
Time frame: Baseline and 6 months.
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8 Non-Invasive Tear Film Break-Up Time (NIF-BUT)
Change in tear film stability measured non-invasively using the Sirius device.
Time frame: Baseline and 6 months