NCT05433428

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2020

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 3, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2020

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

June 27, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2023

Completed
Last Updated

June 27, 2022

Status Verified

June 1, 2022

Enrollment Period

2.4 years

First QC Date

August 10, 2020

Last Update Submit

June 21, 2022

Conditions

Dry Eye SyndromesCataract

Keywords

MetabolomicsDry Eye SyndromeCataract surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Spherical equivalent refraction

    6 weeks

  • Refractive cylinder

    6 weeks

Study Arms (3)

Cataract patients with dry eye - standard treatment

EXPERIMENTAL

Standard pre and postop medication, preservative eye drops.

Drug: Preservative

Cataract patients with dry eye - intensive treatment

OTHER

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

Drug: Lubricant Eye DropsDrug: Preservative Free

Cataract patients without dry eye disease / control group

OTHER

Standard pre and postop medication, control group.

Drug: Preservative

Interventions

Lubricant Eye DropsDRUG

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

Cataract patients with dry eye - intensive treatment
Preservative FreeDRUG

Preservative free eye drops

Cataract patients with dry eye - intensive treatment
PreservativeDRUG

Eyedrops with preservatives

Cataract patients with dry eye - standard treatmentCataract patients without dry eye disease / control group

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ifocus øyeklinikk

Haugesund, 5521, Norway

RECRUITING

MeSH Terms

Conditions

Dry Eye SyndromesCataract

Interventions

Lubricant Eye DropsPreservatives, Pharmaceutical

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesLens Diseases

Intervention Hierarchy (Ancestors)

Ophthalmic SolutionsPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesLubricantsSpecialty Uses of ChemicalsPharmaceutic Aids

Study Officials

  • Morten Gundersen, MD

    IFocus Øyeklinikk AS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Morten Gundersen, MD

CONTACT

+4748157846morten@ifocus.no

Kjell Gundersen, MD

CONTACT

+4791648707kg@ifocus.no

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2020

First Posted

June 27, 2022

Study Start

August 3, 2020

Primary Completion

January 10, 2023

Study Completion

May 23, 2023

Last Updated

June 27, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)