Cataract Senile, Dry Eye Disease, Dry Eye Syndromes, Meibomian Gland Dysfunction
Conditions
Brief summary
This prospective study will investigate the effect of pre-operative Systane iLux system administration in treated cataract induced dry eye disease.
Detailed description
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.
Interventions
DEVICESystane iLux Treatment
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.
Sponsors
George Washington University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Lipid Layer Thickness (LLT) From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Score From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up | 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. |
| Change in Ocular Surface Disease Index (OSDI) Questionnaire Score From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up | 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. |
| Change in Meibomian Gland Score From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKeith Wroblewski, MD
George Washington MFA
Participant flow
Recruitment details
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.
Pre-assignment details
Analyses were conducted at the participant level. For objective ophthalmic measures, assessments were performed in the eye undergoing cataract surgery (one eye per participant).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 15 |
| other Total, other adverse events | 0 / 14 | 0 / 15 |
| serious Total, serious adverse events | 0 / 14 | 0 / 15 |
Outcome results
None listed