Trial Outcomes & Findings for Preoperative iLux on Cataract Surgery Derived Dry Eye Disease Due to Meibomian Gland Dysfunction (NCT NCT06483750)

Participants scheduled for cataract surgery were recruited in clinic (N=30; 15 assigned to treatment, 15 to control). The treatment arm received Systane iLux therapy at the baseline visit (2 weeks prior to surgery), while the control arm received no iLux treatment. Assessments included TBUT, SPEED, OSDI, lipid layer thickness, and meibomian gland score and were performed at baseline and repeated at 4 weeks after cataract surgery to evaluate change from baseline.

Analyses were conducted at the participant level. For objective ophthalmic measures, assessments were performed in the eye undergoing cataract surgery (one eye per participant).

Race and Ethnicity were not collected from any participant.

Lipid layer thickness (LLT) was measured using LipiView II and reported in nanometers (nm). Higher values indicate a thicker lipid layer and improved tear film stability. Assessments were performed at both time points in the eye undergoing cataract surgery (one eye per participant). Change was calculated as the value at 4 weeks post-operatively minus the value at baseline. Negative values indicate a decrease from baseline.

The SPEED questionnaire assesses dry eye symptom severity on a scale from 0 to 64, with higher scores indicating more severe symptoms. Assessments were performed at both time points. Change was calculated as the score at 4 weeks post-operatively minus the score at baseline. Negative values indicate improvement in symptoms.

The OSDI questionnaire assesses dry eye symptom severity on a scale from 0 to 100, with higher scores indicating more severe symptoms. Assessments were performed at both time points. Change was calculated as the score at 4 weeks post-operatively minus the score at baseline. Negative values indicate improvement in symptoms.

Meibomian gland morphology was assessed using infrared meibography with the LipiView II system. Gland dropout was graded on a standardized ordinal scale from 0 to 3 (0 = no gland loss; 3 = \>66% gland loss), with higher scores indicating greater structural gland loss. Assessments were performed at both time points in the eye undergoing cataract surgery (one eye per participant). Analyses were conducted at the participant level. Change was calculated as the score at 4 weeks post-operatively minus the score at baseline. Positive values indicate worsening gland loss.