CLARITY Imaging Study

• Sponsor: Imperial College London (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03758859
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 6.6
• Patients Per Site Per Month: 12.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Other: sodium hyaluronate eyedrops	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: N/A
• Intervention 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
• Primary Purpose: Diagnostic
• Official Title: CLARITY Imaging Study: The Effect Of Cross-linked Sodium Hyaluronate On The Quality Of Optical Coherence Tomography Imaging
• Actual Study Start Date: Apr 12, 2019
• Anticipated Primary Completion Date: Oct 31, 2019
• Anticipated Study Completion Date: Oct 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: sodium hyaluronate eyedrops; sodium hyaluronate eyedrops administered - route ocular -topical

Outcome Measures

Primary Outcome Measures

1. Clarity of retinal images obtained by Optical Coherence Tomography. [immediately after the administration of drops.]

   Signal strength of OCT scan

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Western Eye Hospital	London		United Kingdom	NW1 5QH

Sponsors and Collaborators

• Imperial College London

Investigators

• Principal Investigator: Timothy Yap, Imperial College NHS Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Imperial College London
• ClinicalTrials.gov Identifier: NCT03758859
• Other Study ID Numbers: 18SM4868
• First Posted: Nov 29, 2018
• Last Update Posted: Sep 4, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Imperial College London: Glaucoma
• Additional relevant MeSH terms: Glaucoma; Ophthalmic Solutions; Hyaluronic Acid

Study Results

No Results Posted as of Sep 4, 2019