The Influences of Dry Eye Disease on Optical Quality

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye; Vision; Disturbance, Hysterical

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.

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Aged between 18-65 years old.

Description

Inclusion Criteria:

1. patients were diagnosed as dry eye according to the criteria provided by the Dry Eye Workshop (DEWS)
2. positive corneal fluorescein staining (CFS)
3. 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Normal; healthy subjects
Dry eye group; patients with dry eye
Dry eye after treatment; patients with dry eye after treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Chair: Hong Qi, MD,Phd, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: December 5, 2018
• First Submitted That Met QC Criteria: July 31, 2019
• First Posted (Actual): August 2, 2019

Study Record Updates

• Last Update Posted (Actual): August 2, 2019
• Last Update Submitted That Met QC Criteria: July 31, 2019
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: DEDOQ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No