CLARITY Imaging Study | NCT03758859

Studies
CLARITY Imaging Study

NCT03758859

Sponsor

Imperial College London

Status

Unknown status

Last Update Posted

Sep 4, 2019Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Glaucoma

Interventions

sodium hyaluronate eyedrops

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 12, 2019Actual

Primary Completion Date

Oct 31, 2019Estimated

Completion Date

Oct 31, 2019Estimated

First Submitted Date

Nov 27, 2018

First Submission Date that Met QC Criteria

Nov 28, 2018

First Posted Date

Nov 29, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2019

Last Update Posted Date

Sep 4, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
sodium hyaluronate eye drops	Experimental	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.	Other: sodium hyaluronate eyedrops

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sodium hyaluronate eyedrops	Other	sodium hyaluronate eyedrops administered - route ocular -topical	sodium hyaluronate eye drops

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clarity of retinal images obtained by Optical Coherence Tomography.	Signal strength of OCT scan	immediately after the administration of drops.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Serge Miodragovic	Contact	+442033123206	23206	serge.miodragovic1@nhs.net
Timothy Yap	Contact	+442033123206	23206	timothyedward.yap@nhs.net

Overall Officials

Name	Affiliation	Role
Timothy Yap	Imperial College NHS Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Western Eye Hospital	Recruiting	London		NW1 5QH	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Mar 13, 2024
Reset	Aug 21, 2024

Submission Tracking

Estimated Results First Submitted Date

Mar 13, 2024

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Mar 13, 2024			Aug 21, 2024

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

None (Open Label)

Masking Description

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

Who Masked

Not provided