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Metabolomic Profile in Tear Film Samples of Patients With or Without Dry Eye Syndrome Before and After Cataract Surgery.
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.
The participants will be randomized to either standard pre- and postoperative treatment protocol - hereby called the standard protocol - or a pre- and postoperative protocol where intensive dry eye treatment is implemented - hereby called the intensive dry eye treatment protocol. The intensive dry eye treatment protocol differs from the standard protocol in the use of preservative free eye drops and the use of topical steroids prior to surgery. The standard treatment protocol is: Before surgery: * Nevanac 3 mg /mL * Spersadex 1mg/ml three days before surgery. After surgery: Nevanac 3 mg /mL five days after surgery. Spersadex 1 mg/ml 20 days after surgery The intensive dry eye treatment protocol is: Before surgery: Lubricants (Thealoz Duo) for four weeks. Preservative free dexamethasone 0.1% (Monopex) drops for one week Preservative free Diklofenak 1mg/mL drops (Voltaren minims) four times a day from three days before surgery. After surgery: Lubricants (Thealoz Duo) for three weeks. Preservative free dexamethasone 0.1% (Monopex) drops for three weeks. Preservative free Diklofenak 1mg/mL drops (Voltaren minims) for five days after surgery. Biometry will be performed prior to and after the preoperative treatment, 6 weeks after surgery. The variability in biometry measurements will be assessed for the standard protocol group versus the intensive dry eye protocol group. In addition, the average difference in estimated refraction and the actual refractive outcome (deltaR) will be calculated for both groups. Differences in tear film instability before and after preoperative treatment, 6 weeks after surgery will be investigated. Other variables to be investigated: Average corneal curvature (K) Anterior corneal curvature Corneal astigmatism Mean spherical equivalent Dioptric keratometric power (estimated Intraocular lens (IOL) power) Best corrected visual acuity Tearlab osmolarity Non-invasive break up time(NIBUT) Tear meniscus height Bulbar redness grade Tear film lipid layer thickness (Lipiview) Ocular scatter analysis (HD analyzer) Cochet-Bonnet esthesiometry Ocular surface staining(OSS) Schirmers I test (without anesthetics) Meibum expressibility Meibum quality Meibomian gland dropout (meibography) Lid margin irregularities (yes/no) Tarsal conjunctival follicles/papillae (yes/no) Ocular surface disease index(OSDI) Dry Eye Quality of life questionnaire-5 (DEQ-5) Standard Patient Evaluation of Eye Dryness II (SPEED II)
Age
40 - 90 years
Sex
ALL
Healthy Volunteers
Yes
Ifocus øyeklinikk
Haugesund, Norway
Start Date
August 3, 2020
Primary Completion Date
January 10, 2023
Completion Date
May 23, 2023
Last Updated
June 27, 2022
250
ESTIMATED participants
Lubricant Eye Drops
DRUG
Preservative Free
DRUG
Preservative
DRUG
Lead Sponsor
Ifocus Oyeklinikk
Collaborators
NCT06979752
NCT07362043
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06060041