CLARITY Imaging Study

NCT ID: NCT03758859

Last Updated: 2019-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-12

Study Completion Date

2019-10-31

Brief Summary

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OCT image quality is necessary to provide accurate diagnostic information to ophthalmologists. The increasing resolution of imaging techniques will require ever more high standards of optical transmission through the cornea and tear film. Given that lubricant drops can improve optical transmission through the cornea, this study will attempt to quantify this. The primary objective is to assess the effect of cross-linked sodium hyaluronate on OCT image quality compared to the effect of blinking alone.

Detailed Description

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Conditions

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Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Randomisation is between eyes i.e. eye exposed to blinking alone vs eye exposed to lubricant drops

Study Groups

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sodium hyaluronate eye drops

the randomly allocated eye will receive sodium hyaluronate drops, followed by a repeat OCT scan; images are then evaluated for clarity by the masked assessor.

Group Type EXPERIMENTAL

sodium hyaluronate eyedrops

Intervention Type OTHER

sodium hyaluronate eyedrops administered - route ocular -topical

Interventions

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sodium hyaluronate eyedrops

sodium hyaluronate eyedrops administered - route ocular -topical

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients subjectively deemed to have poor image quality by the photographer

Exclusion Criteria

* Patients with a known adverse reaction to any of the constituents of the XLHA
* Patients wearing contact lenses
* Patients who have used eyedrops in the past 2 hours
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Timothy Yap

Role: PRINCIPAL_INVESTIGATOR

Imperial College NHS Trust

Locations

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Western Eye Hospital

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Serge Miodragovic

Role: CONTACT

+442033123206 ext. 23206

Timothy Yap

Role: CONTACT

+442033123206 ext. 23206

Facility Contacts

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Serge Miodragovic

Role: primary

+44 2033123206 ext. 23206

Timothy Yap

Role: backup

+44 2033123206 ext. 23206

Other Identifiers

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18SM4868

Identifier Type: -

Identifier Source: org_study_id

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