Metabolomic Profile in Dry Eye Syndrome Patients.

NCT ID: NCT05433428

Last Updated: 2022-06-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-03
• Study Completion Date: 2023-05-23

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)

Conditions

Dry Eye Syndromes; Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cataract patients with dry eye - standard treatment

Standard pre and postop medication, preservative eye drops.

Group Type: EXPERIMENTAL

Preservative

Intervention Type: DRUG

Eyedrops with preservatives

Cataract patients with dry eye - intensive treatment

More prolonged use of lubricant eye drops as well as the use of preservative free eye drops.

Group Type: OTHER

Lubricant Eye Drops

Intervention Type: DRUG

Prolonged use of lubricant eye drops pre and post-op.

Preservative Free

Intervention Type: DRUG

Preservative free eye drops

Cataract patients without dry eye disease / control group

Standard pre and postop medication, control group.

Group Type: OTHER

Preservative

Intervention Type: DRUG

Eyedrops with preservatives

Interventions

Lubricant Eye Drops

Prolonged use of lubricant eye drops pre and post-op.

Intervention Type: DRUG

Preservative Free

Preservative free eye drops

Intervention Type: DRUG

Preservative

Eyedrops with preservatives

Intervention Type: DRUG

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Research Council of Norway

OTHER

Sponsor Role: collaborator

Ifocus Oyeklinikk

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Morten Gundersen, MD

Role: PRINCIPAL_INVESTIGATOR

IFocus Øyeklinikk AS

Locations

Ifocus øyeklinikk

Haugesund, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Morten Gundersen, MD

Role: CONTACT

morten@ifocus.no

+4748157846

Kjell Gundersen, MD

Role: CONTACT

kg@ifocus.no

+4791648707

Facility Contacts

Morten Gundersen, Dr

Role: primary

morten@ifocus.no

48157846

Kjell Gunnar Gundersen, Dr.med

Role: backup

kg@ifocus.no

91648707

Other Identifiers

140664

Identifier Type: -

Identifier Source: org_study_id