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This prospective study will investigate the effect of pre-operative Systane iLux system administration in treated cataract induced dry eye disease.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control: No Systane iLux Treatment | No Intervention | No Systane iLux treatment at baseline visit two weeks prior to cataract surgery. | |
| Systane iLux Treatment | Experimental | Systane iLux administration at baseline visit two weeks prior to cataract surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Lipid Layer Thickness (LLT) From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up | 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. | Baseline (2 weeks prior to cataract surgery) and 4 weeks after cataract surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keith Wroblewski, MD | George Washington MFA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Washington University | Washington D.C. | District of Columbia | 20037 | United States |
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Analyses were conducted at the participant level. For objective ophthalmic measures, assessments were performed in the eye undergoing cataract surgery (one eye per participant).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control: No Systane iLux Treatment | No Systane iLux treatment at the baseline visit (2 weeks prior to cataract surgery) |
| FG001 | Systane iLux Treatment | Systane iLux treatment was administered at the baseline visit (2 weeks prior to cataract surgery) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control: No Systane iLux Treatment | No Systane iLux treatment at baseline visit two weeks prior to cataract surgery. |
| BG001 | Systane iLux Treatment | Systane iLux administration at baseline visit two weeks prior to cataract surgery. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Lipid Layer Thickness (LLT) From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up | 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. | Analyses were conducted at the participant level. For objective ophthalmic measures, assessments were performed in the eye undergoing cataract surgery (one eye per participant) | Posted | Mean | Standard Deviation | Nanometers | Baseline (2 weeks prior to cataract surgery) and 4 weeks after cataract surgery |
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From baseline visit (2 weeks prior to cataract surgery) through 4 weeks post-operative follow-up
Adverse events were monitored from baseline (2 weeks prior to cataract surgery) through 4 weeks post-operative follow-up at scheduled study visits and via participant report. No serious adverse events were reported during the study period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control: No Systane iLux Treatment | No Systane iLux treatment at baseline visit two weeks prior to cataract surgery |
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The sample size was relatively small, which may limit the statistical power and generalizability of the findings. Additionally, the follow up period was limited. Future studies with a larger cohort and a longer follow up duration would be beneficial to better evaluate the durability of treatment effects. Incorporating multiple follow up assessments at additional time points would also help characterize the temporal response to treatment and determine whether improvements in ocular surface parame
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arnold Leigh | George Washington University SMHS | 703-967-0226 | arnold.leigh@gwu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 12, 2026 | May 14, 2026 | Prot_SAP_ICF_002.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D000080343 | Meibomian Gland Dysfunction |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D005141 | Eyelid Diseases |
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| Baseline (2 weeks prior to cataract surgery) and 4 weeks after cataract surgery |
| Change in Ocular Surface Disease Index (OSDI) Questionnaire Score From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up | 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. | Baseline (2 weeks prior to cataract surgery) and 4 weeks after cataract surgery |
| Change in Meibomian Gland Score From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up | 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. | Baseline (2 weeks prior to cataract surgery) and 4 weeks after cataract surgery |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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No Systane iLux treatment at baseline visit two weeks prior to cataract surgery.
| OG001 | Systane iLux Treatment | Systane iLux administration at baseline visit two weeks prior to cataract surgery. |
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| Secondary | 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 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. | Analyses were conducted at the participant level. For objective ophthalmic measures, assessments were performed in the eye undergoing cataract surgery (one eye per participant) | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (2 weeks prior to cataract surgery) and 4 weeks after cataract surgery |
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| Secondary | Change in Ocular Surface Disease Index (OSDI) Questionnaire Score From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up | 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. | Analyses were conducted at the participant level. For objective ophthalmic measures, assessments were performed in the eye undergoing cataract surgery (one eye per participant) | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (2 weeks prior to cataract surgery) and 4 weeks after cataract surgery |
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| Secondary | Change in Meibomian Gland Score From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up | 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. | Analyses were conducted at the participant level. For objective ophthalmic measures, assessments were performed in the eye undergoing cataract surgery (one eye per participant) | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (2 weeks prior to cataract surgery) and 4 weeks after cataract surgery |
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| 14 |
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| 14 |
| EG001 | Systane iLux Treatment | Systane iLux administration at baseline visit two weeks prior to cataract surgery | 0 | 15 | 0 | 15 | 0 | 15 |
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