Metabolomic Profile in Dry Eye Syndrome Patients.

Phase 4

• Conditions: Dry Eye Syndromes; Cataract
• Interventions: Drug: Preservative; Drug: Lubricant Eye Drops; Drug: Preservative Free

• Registration Number: NCT05433428
• Lead Sponsor: Ifocus Oyeklinikk

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)

Study Timeline

• Study Start: 2020-08-03
• Study First Submitted: 2020-08-10
• Status Verified: 2022-06
• Study First Submitted QC: 2022-06-21
• Last Update Submitted: 2022-06-21
• Study First Posted: 2022-06-27
• Last Update Posted: 2022-06-27
• Primary Completion: 2023-01-10
• Study Completion: 2023-05-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cataract patients with dry eye - standard treatment	Preservative	Standard pre and postop medication, preservative eye drops.
Cataract patients with dry eye - intensive treatment	Lubricant Eye Drops	More prolonged use of lubricant eye drops as well as the use of preservative free eye drops.
Cataract patients with dry eye - intensive treatment	Preservative Free	More prolonged use of lubricant eye drops as well as the use of preservative free eye drops.
Cataract patients without dry eye disease / control group	Preservative	Standard pre and postop medication, control group.

Primary Outcome Measures

Name	Time	Method
Metabolomic and lipodomic profile	6 weeks	The metabolomic and lipodomic profiles of the tears in each group will be measured. Relevant metabolic/lipid results will be reported.

Secondary Outcome Measures

Name	Time	Method
Spherical equivalent refraction	6 weeks	Spherical equivalent refraction in diopters.
Refractive cylinder	6 weeks	Refractive cylinder in diopters.

Trial Locations

Locations (1)

Ifocus øyeklinikk; 🇳🇴 Haugesund, Norway