Trial results for a study investigating preoperative Systane iLux system administration in patients with Dry Eye Disease due to Meibomian Gland Dysfunction undergoing cataract surgery were posted on ClinicalTrials.gov on 2026-05-15. The study found that Systane iLux treatment led to a mean increase of 19.5 Nanometers in lipid layer thickness.
Background
Dry Eye Disease (DED) is a prevalent ocular condition characterized by symptoms such as discomfort, visual disturbance, and tear film instability. Meibomian Gland Dysfunction (MGD), a chronic and diffuse abnormality of the meibomian glands, is a leading cause of evaporative DED. Patients undergoing cataract surgery are particularly susceptible to developing or experiencing exacerbation of DED, which can impact post-operative comfort and visual recovery. Addressing MGD preoperatively may mitigate these issues and improve overall patient outcomes.
Trial design
This completed study, identified as Phase NA, enrolled 30 participants. The trial investigated the effect of preoperative Systane iLux system administration in patients with Dry Eye Disease, Meibomian Gland Dysfunction, and Cataract Senile, also categorized under Dry Eye Syndromes. The intervention involved the Systane iLux treatment, while the control group received no Systane iLux treatment. The study aimed to assess changes in various ocular parameters from two weeks pre-operative baseline to four weeks post-operative follow-up.
Key results
The trial results indicate improvements in both objective and subjective measures for the Systane iLux treatment group compared to the control group:
- Change in Lipid Layer Thickness (LLT) From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up: The Systane iLux treatment group showed a mean increase of 19.5 Nanometers (Standard Deviation: 4.4 Nanometers), while the control group experienced a mean decrease of -1.9 Nanometers (Standard Deviation: 4.6 Nanometers).
- Change in Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Score From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up: The Systane iLux treatment group had a mean decrease of -3.4 Scores on a scale (Standard Deviation: 1.7 Scores on a scale), indicating improvement in symptoms. The control group showed a mean increase of 0.6 Scores on a scale (Standard Deviation: 2.0 Scores on a scale).
- Change in Ocular Surface Disease Index (OSDI) Questionnaire Score From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up: The Systane iLux treatment group demonstrated a mean decrease of -11.8 Scores on a scale (Standard Deviation: 3.9 Scores on a scale), signifying improved ocular comfort and function. The control group had a mean decrease of -0.1 Scores on a scale (Standard Deviation: 3.8 Scores on a scale).
- Change in Meibomian Gland Score From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up: The Systane iLux treatment group showed a mean decrease of -0.27 Scores on a scale (Standard Deviation: 0.46 Scores on a scale), suggesting an improvement in meibomian gland health. The control group had a mean increase of 0.21 Scores on a scale (Standard Deviation: 0.43 Scores on a scale).
What this means
The findings suggest that preoperative administration of the Systane iLux system can positively impact patients with Dry Eye Disease due to Meibomian Gland Dysfunction undergoing cataract surgery. The significant increase in lipid layer thickness, coupled with reductions in patient-reported dry eye symptoms (SPEED and OSDI scores) and an improved Meibomian Gland Score, indicates a beneficial effect of the treatment. These results imply that such an intervention could potentially enhance the ocular surface environment before surgery, leading to better post-operative comfort and potentially improved visual outcomes for this patient population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT06483750, titled "Preoperative iLux on Cataract Surgery Derived Dry Eye Disease Due to Meibomian Gland Dysfunction", were posted on 2026-05-15 on clinicaltrials.gov.