NCT03758859

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.

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
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 29, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

April 12, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

September 4, 2019

Status Verified

September 1, 2019

Enrollment Period

7 months

First QC Date

November 27, 2018

Last Update Submit

September 2, 2019

Conditions

Glaucoma

Keywords

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Clarity of retinal images obtained by Optical Coherence Tomography.

    Signal strength of OCT scan

    immediately after the administration of drops.

Study Arms (1)

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

sodium hyaluronate eyedropsOTHER

sodium hyaluronate eyedrops administered - route ocular -topical

sodium hyaluronate eye drops

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Eye Hospital

London, NW1 5QH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Timothy Yap

    Imperial College NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Serge Miodragovic

CONTACT

+442033123206serge.miodragovic1@nhs.net

Timothy Yap

CONTACT

+442033123206timothyedward.yap@nhs.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Randomisation is between eyes i.e. eye exposed to blinking alone vs eye exposed to lubricant drops
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2018

First Posted

November 29, 2018

Study Start

April 12, 2019

Primary Completion

October 31, 2019

Study Completion

October 31, 2019

Last Updated

September 4, 2019

Record last verified: 2019-09

Locations

GB(1)