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Completed

NCT Number: NCT06483750

Preoperative iLux on Cataract Surgery Derived Dry Eye Disease Due to Meibomian Gland Dysfunction

This prospective study will investigate the effect of pre-operative Systane iLux system administration in treated cataract induced dry eye disease.

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Key information

Conditions

Dry Eye Disease Cataract Senile Dry Eye Syndromes Eye Diseases Eyelid Diseases Lacrimal Apparatus Diseases Meibomian Gland Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

George Washington University

Washington D.C., District of Columbia, 20037, United States

About this study

Eligible patients to be recruited will have scheduled upcoming senile cataract surgery. Enrolled patients in the active arm (n=25) will receive pre-operative Systane iLux treatment two weeks prior to surgery at the baseline visit. Patients in the control arm will receive no Systane iLux treatment at the baseline visit two weeks prior to cataract surgery. Patients will be assessed on baseline metrics for dry eye disease stemming and meibomian gland dysfunction (MGD) at the baseline visit two weeks prior to cataract surgery. These metrics include tear break up time (TBUT), standard patient evaluation of eye dryness questionnaire (SPEED), ocular surface and surface disease index (OSDI) surveys, and lipid layer thickness (LLT). At the follow up visit four weeks after cataract surgery, these same metrics will be assessed again for any significant changes.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age greater than 18 at the time of informed consent
  • Must understand; be willing and able, and likely to fully comply with study procedures, visit schedule, and restrictions
  • Upcoming scheduled senile cataract surgery

Exclusion criteria

  • Eyelid abnormalities
  • Patients with active ocular infection, active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months
  • Ocular surgery within the last 6 months
  • Occlusion therapy with lacrimal or punctum plugs within the last 3 months
  • Patients with an ocular surface abnormality that may compromise corneal integrity
  • Patients with ocular injury or trauma, chemical burns, or limbal stem cell deficiency (within prior 3 months)
  • Patients with cicatricial lid margin disease
  • patients with lid surface abnormalities that affect lid function in either eye; patients with aphakia
  • Patients with permanent makeup or tattoos on their eyelids.
  • Previous application/administration of Systane iLux or LipiFlow treatment

Treatment and study plan

Systane iLux Treatment

Device

The Systane iLux is an approved thermal pulsation device to treat dry eye disease. The application of heat and compression to both eyelids melts meibum in the obstructed glands to restore the secretion and production of meibum to the eye. The Systane iLux will only be administered to the eye to undergo cataract surgery.

Primary outcomes

  1. Change in Lipid Layer Thickness (LLT) From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up

    Time frame: Baseline (2 weeks prior to cataract surgery) and 4 weeks after cataract surgery

    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.

Secondary outcomes

  1. Change in Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Score From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up

    Time frame: Baseline (2 weeks prior to cataract surgery) and 4 weeks after cataract surgery

    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.

  2. Change in Ocular Surface Disease Index (OSDI) Questionnaire Score From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up

    Time frame: Baseline (2 weeks prior to cataract surgery) and 4 weeks after cataract surgery

    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.

  3. Change in Meibomian Gland Score From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up

    Time frame: Baseline (2 weeks prior to cataract surgery) and 4 weeks after cataract surgery

    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.

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Registry information

Official study title

The Efficacy of the Systane iLux System on Preoperative Cataract Patients on Dry Eye Disease Due to Meibomian Gland Dysfunction

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 3, 2024
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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