Metabolomic Profile in Dry Eye Syndrome Patients.

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.

Study Overview

• Status: Recruiting
• Conditions: Cataract; Dry Eye Syndromes
• Intervention / Treatment: Drug: Preservative; Drug: Lubricant Eye Drops; Drug: Preservative Free

Detailed Description

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)

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Morten Gundersen, MD; Phone Number: +4748157846; Email: morten@ifocus.no
• Study Contact Backup: Name: Kjell Gundersen, MD; Phone Number: +4791648707; Email: kg@ifocus.no

Study Locations

• Norway
  • Haugesund, Norway, 5521
    • Recruiting
    • Ifocus øyeklinikk
    • Contact: Morten Gundersen, Dr; Phone Number: 48157846; Email: morten@ifocus.no
    • Contact: Kjell Gunnar Gundersen, Dr.med; Phone Number: 91648707; Email: kg@ifocus.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cataract patients with dry eye - standard treatment; Standard pre and postop medication, preservative eye drops.	Drug: Preservative; Eyedrops with preservatives
Other: Cataract patients with dry eye - intensive treatment; More prolonged use of lubricant eye drops as well as the use of preservative free eye drops.	Drug: Lubricant Eye Drops; Prolonged use of lubricant eye drops pre and post-op.; Drug: Preservative Free; Preservative free eye drops
Other: Cataract patients without dry eye disease / control group; Standard pre and postop medication, control group.	Drug: Preservative; Eyedrops with preservatives

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spherical equivalent refraction	Spherical equivalent refraction in diopters.	6 weeks
Refractive cylinder	Refractive cylinder in diopters.	6 weeks

Collaborators and Investigators

• Sponsor: Ifocus Oyeklinikk
• Collaborators: The Research Council of Norway
• Investigators: Principal Investigator: Morten Gundersen, MD, IFocus Øyeklinikk AS

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2020
• Primary Completion (Anticipated): January 10, 2023
• Study Completion (Anticipated): May 23, 2023

Study Registration Dates

• First Submitted: August 10, 2020
• First Submitted That Met QC Criteria: June 21, 2022
• First Posted (Actual): June 27, 2022

Study Record Updates

• Last Update Posted (Actual): June 27, 2022
• Last Update Submitted That Met QC Criteria: June 21, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Cataract surgery; Metabolomics; Dry Eye Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Lens Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Syndrome; Cataract; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions; Lubricant Eye Drops
• Other Study ID Numbers: 140664

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No