The Influences of Dry Eye Disease on Optical Quality | NCT04043949

Studies
The Influences of Dry Eye Disease on Optical Quality

NCT04043949

Sponsor

Peking University Third Hospital

Status

Completed

Last Update Posted

Aug 2, 2019Actual

Enrollment

90Actual

Phase

Not provided

Conditions

Dry Eye
Vision; Disturbance, Hysterical

Interventions

Not provided

Countries

China

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2017Actual

Primary Completion Date

Jul 1, 2018Actual

Completion Date

Jul 1, 2018Actual

First Submitted Date

Dec 5, 2018

First Submission Date that Met QC Criteria

Jul 31, 2019

First Posted Date

Aug 2, 2019Actual

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

Jul 31, 2019

Last Update Posted Date

Aug 2, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

DED could result in visual disturbance and damage optical quality. We aimed to evaluate the influences of dry eye disease (DED) on optical quality and their correlations.

Detailed Description

This study is aimed at evaluating changes of optical quality in dry eye patients with superficial punctate keratopathy after being treated by artificial lubricant and anti-inflammatory eye drops.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Normal		healthy subjects
Dry eye group		patients with dry eye
Dry eye after treatment		patients with dry eye after treatment

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The severity of DED influenced the optical quality of dry eye patients	The optical quality of dry eye patients	2017.7-2019.7
High order abberations	cornela high order abberations of patients	2017.7-2019.7

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients were diagnosed as dry eye according to the criteria provided by the Dry Eye Workshop (DEWS)
positive corneal fluorescein staining (CFS)
best-corrected distance visual acuity better than 20/20.

Exclusion Criteria:

History of ocular surgeries, contact lens wear, meibomian gland dysfunction, and any type of corneal scarring such as dystrophies or infections.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Aged between 18-65 years old.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hong Qi, MD,Phd	Peking University Third Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Third Hospital		Beijing	Beijing Municipality	100191	China

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

Condition Browse Module

MeSH Terms

ID	Term
D015352	Dry Eye Syndromes

Ancestor Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided