Metabolomic Profile in Dry Eye Syndrome Patients.
Primary Purpose
Dry Eye Syndromes, Cataract
Status
Recruiting
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Lubricant Eye Drops
Preservative Free
Preservative
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndromes focused on measuring Metabolomics, Dry Eye Syndrome, Cataract surgery
Eligibility Criteria
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.
Sites / Locations
- Ifocus øyeklinikkRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Other
Other
Arm Label
Cataract patients with dry eye - standard treatment
Cataract patients with dry eye - intensive treatment
Cataract patients without dry eye disease / control group
Arm Description
Standard pre and postop medication, preservative eye drops.
More prolonged use of lubricant eye drops as well as the use of preservative free eye drops.
Standard pre and postop medication, control group.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Spherical equivalent refraction
Spherical equivalent refraction in diopters.
Refractive cylinder
Refractive cylinder in diopters.
Full Information
NCT ID
NCT05433428
First Posted
August 10, 2020
Last Updated
June 21, 2022
Sponsor
Ifocus Oyeklinikk
Collaborators
The Research Council of Norway
1. Study Identification
Unique Protocol Identification Number
NCT05433428
Brief Title
Metabolomic Profile in Dry Eye Syndrome Patients.
Official Title
Metabolomic Profile in Tear Film Samples of Patients With or Without Dry Eye Syndrome Before and After Cataract Surgery.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2020 (Actual)
Primary Completion Date
January 10, 2023 (Anticipated)
Study Completion Date
May 23, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ifocus Oyeklinikk
Collaborators
The Research Council of Norway
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes, Cataract
Keywords
Metabolomics, Dry Eye Syndrome, Cataract surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cataract patients with dry eye - standard treatment
Arm Type
Experimental
Arm Description
Standard pre and postop medication, preservative eye drops.
Arm Title
Cataract patients with dry eye - intensive treatment
Arm Type
Other
Arm Description
More prolonged use of lubricant eye drops as well as the use of preservative free eye drops.
Arm Title
Cataract patients without dry eye disease / control group
Arm Type
Other
Arm Description
Standard pre and postop medication, control group.
Intervention Type
Drug
Intervention Name(s)
Lubricant Eye Drops
Intervention Description
Prolonged use of lubricant eye drops pre and post-op.
Intervention Type
Drug
Intervention Name(s)
Preservative Free
Intervention Description
Preservative free eye drops
Intervention Type
Drug
Intervention Name(s)
Preservative
Intervention Description
Eyedrops with preservatives
Primary Outcome Measure Information:
Title
Metabolomic and lipodomic profile
Description
The metabolomic and lipodomic profiles of the tears in each group will be measured. Relevant metabolic/lipid results will be reported.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Spherical equivalent refraction
Description
Spherical equivalent refraction in diopters.
Time Frame
6 weeks
Title
Refractive cylinder
Description
Refractive cylinder in diopters.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Morten Gundersen, MD
Phone
+4748157846
Email
morten@ifocus.no
First Name & Middle Initial & Last Name or Official Title & Degree
Kjell Gundersen, MD
Phone
+4791648707
Email
kg@ifocus.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morten Gundersen, MD
Organizational Affiliation
IFocus Øyeklinikk AS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ifocus øyeklinikk
City
Haugesund
ZIP/Postal Code
5521
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morten Gundersen, Dr
Phone
48157846
Email
morten@ifocus.no
First Name & Middle Initial & Last Name & Degree
Kjell Gunnar Gundersen, Dr.med
Phone
91648707
Email
kg@ifocus.no
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Metabolomic Profile in Dry Eye Syndrome Patients.
We'll reach out to this number within 24 hrs