Cataract Clinical Trial
Official title:
Metabolomic Profile in Tear Film Samples of Patients With or Without Dry Eye Syndrome Before and After Cataract Surgery.
NCT number | NCT05433428 |
Other study ID # | 140664 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | August 3, 2020 |
Est. completion date | May 23, 2023 |
The primary objective is to determine possible implications of deviant tear film quality for optimal refractive precision in patients scheduled for cataract surgery. The study consist of three separate arms where cataract patients will be separated in to Dry Eye Disease (DED) positive and negative groups. The DED positive group will be further subdivided into two different treatment groups (with focus on prolonged use of lubricant and preservative free eye drops). Tear film samples will be taken before treatment, after treatment and after surgical treatment and compared.
Status | Recruiting |
Enrollment | 250 |
Est. completion date | May 23, 2023 |
Est. primary completion date | January 10, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 90 Years |
Eligibility | Inclusion Criteria: - Indication for cataract surgery - Signed informed consent - no rheumatological or other systemic disease that involve the corneal surface - a good ocular health with no pathology that compromises visual acuity (except cataract). Exclusion Criteria: - Manifest corneal disease or scarring - Lid deformities - Corneal ectasia - Rheumatoid diseases or other systemic diseases that involve the corneal surface, - Recent ocular surgery - Previous refractive procedures - Diabetic retinopathy - Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness) - Pregnancy. |
Country | Name | City | State |
---|---|---|---|
Norway | Ifocus øyeklinikk | Haugesund |
Lead Sponsor | Collaborator |
---|---|
Ifocus Oyeklinikk | The Research Council of Norway |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Metabolomic and lipodomic profile | The metabolomic and lipodomic profiles of the tears in each group will be measured. Relevant metabolic/lipid results will be reported. | 6 weeks | |
Secondary | Spherical equivalent refraction | Spherical equivalent refraction in diopters. | 6 weeks | |
Secondary | Refractive cylinder | Refractive cylinder in diopters. | 6 weeks |
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