Cataract Surgery, Dry Eye, Eyes Dry Feeling of, Ocular Surface Disease
Conditions
Brief summary
Dry Eye Disease is defined as "a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface.' 'By the The Tear Film and Ocular Surface Society. Despite there being a number of factors that impact DED however one factor that has been considered likely is that of a complication from ocular surgery itself. Which can cause both corneal nerve, and ocular surface damage. Therefore this study aims to determine how Lacrfill performs in preventing post-operative dry eye symptoms in those who have recently had unilateral cataract surgery.
Interventions
DRUGLacrifill
Participants will receive Lacrifill achemically crosslinked, particulate hyaluronic acid (HA) hydrogel intracanalicular occlusion device that is intended to occlude tear drainage
DRUGSaline
Participants will be provided with a saline eye drop which is standard of care for those recovering from cataract surgery, and other complications that could cause symptoms related to Dry Eye Disease.
Sponsors
Eye Research Associates, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Masking description
The Principal Investigator who is completing the assessments will be masked in order to prevent biasing the study. An unmasked coordinator not involved in the assessment portion of the study will provide information to the study participant regarding the treatment and be in charge of the randomziation.
Intervention model description
Subjects will be randomized to either the Lacrifill group or the saline/standard of care. After eligibility requirements are meant.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adults ≥18 years of age. * Have the potential of 20/40 visual acuity or better post-cataract surgery. * have cataract surgery scheduled for both eyes * Corneal staining score of ≥3 on the original National Eye Institute (NEI; 0-15 total score) staining scale in the study eye. * willing to discontinue contact lens throughout the study? * pre-treatment OSDI scores of ≤12 (asymptomatic)?
Exclusion criteria
* Known systemic health conditions that are known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome)? * History of ocular surgery within the past 12 months (excluding cataract surgery) * Anticipated complications from cataract surgery in either eye? * History of severe ocular trauma, active ocular infection or inflammation that is not dry eye-related? * Used Accutane or is currently using ocular medications/treatments outside of study treatments? Artificial tears will be allowed. * Physical meibomian gland treatment withing 1 month of enrollment? * Having any conditions or are in a situation, which in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may significantly interfere with their participation in the study. * Currently pregnant or breast feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OSDI Scores at the 1-month post-operative visit compared to pre-treatment (0-100 scale) | 1-month post operative compared to pre-treatment | Ocular Surface Disease Index scores will be determined on a scale with higher scores meaning more discomfort. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| • OSDI Scores at the 3-month post-operative visit compared to pre-treatment (0-100 scale). | pre-treatment as compared to 3 months post operative. | Ocular Surface Disease Index scores will be determined on a scale with higher scores meaning more discomfort. |
| Eye Dryness visual analog scale (VAS) Scores 1 month post operative | 1 month post operative as compared to pre-treatment. | The Eye Dryness visual analog scale VAS will be conducted 1 month post operative with higher scores indicating more discomfort. |
| Eye Dryness visual analog scale (VAS) Scores 3 month post operative | 3 month post operative as compared to pre-treatment. | The Eye Dryness visual analog scale VAS will be conducted 3 month post operative with higher scores indicating more discomfort. |
Outcome results
None listed