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CLARITY Imaging Study (CLARITY)

Primary Purpose

Glaucoma

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
sodium hyaluronate eyedrops
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glaucoma focused on measuring Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Western Eye HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

sodium hyaluronate eye drops

Arm Description

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.

Outcomes

Primary Outcome Measures

Clarity of retinal images obtained by Optical Coherence Tomography.
Signal strength of OCT scan

Secondary Outcome Measures

Full Information

First Posted
November 27, 2018
Last Updated
September 2, 2019
Sponsor
Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT03758859
Brief Title
CLARITY Imaging Study
Acronym
CLARITY
Official Title
CLARITY Imaging Study: The Effect Of Cross-linked Sodium Hyaluronate On The Quality Of Optical Coherence Tomography Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 12, 2019 (Actual)
Primary Completion Date
October 31, 2019 (Anticipated)
Study Completion Date
October 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Glaucoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Randomisation is between eyes i.e. eye exposed to blinking alone vs eye exposed to lubricant drops
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sodium hyaluronate eye drops
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
sodium hyaluronate eyedrops
Intervention Description
sodium hyaluronate eyedrops administered - route ocular -topical
Primary Outcome Measure Information:
Title
Clarity of retinal images obtained by Optical Coherence Tomography.
Description
Signal strength of OCT scan
Time Frame
immediately after the administration of drops.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Serge Miodragovic
Phone
+442033123206
Ext
23206
Email
serge.miodragovic1@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Timothy Yap
Phone
+442033123206
Ext
23206
Email
timothyedward.yap@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Yap
Organizational Affiliation
Imperial College NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Eye Hospital
City
London
ZIP/Postal Code
NW1 5QH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serge Miodragovic
Phone
+44 2033123206
Ext
23206
Email
serge.miodragovic1@nhs.net
First Name & Middle Initial & Last Name & Degree
Timothy Yap
Phone
+44 2033123206
Ext
23206
Email
timothyedward.yap@nhs.net

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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CLARITY Imaging Study

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