NCT00050466

Brief Summary

This pilot study will examine the usefulness of a new instrument called the Dynamic Light Scattering (DLS) device for documenting and monitoring changes in the cornea, the front part of the eye where contact lenses are placed. The DLS device uses a low-intensity laser similar to that used in supermarket checkouts to measure the cloudiness of the cornea. The results of this study may lead to further investigations using DLS to discover the cause of corneal clouding and to develop treatments to prevent it. Healthy volunteers and patients with corneal clouding or opacification 18 years of age and older may be eligible for this study. Participants will have a standard eye examination, including a check of visual acuity and eye pressure. The retina will also be examined and photographs of the cornea may be taken. For the DLS test, the subject sits in front of the device and looks at a yellow-green target while the cloudiness of the cornea is measured. Subjects will be tested four times. The entire procedure takes less than 30 minutes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2002

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2002

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

March 4, 2008

Status Verified

September 1, 2005

First QC Date

December 9, 2002

Last Update Submit

March 3, 2008

Conditions

Keywords

Normal VolunteersDynamic Light Scattering (DLS)Corneal OpacitiesCorneaTransparencyVision

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals greater than or equal to 18 years of age.
  • Controls:
  • Control subjects must have normal, clear corneas as determined by slit lamp biomicroscopy and central corneal thickness less than 0.55 mm centrally.
  • Patients:
  • Patients with corneal clouding and opacification.

You may not qualify if:

  • To be eligible, participants must not satisfy the criterion below:
  • Individuals who cannot cooperate or keep still for the DLS measurements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Eye Institute (NEI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Datiles MB 3rd, Ansari RR, Reed GF. A clinical study of the human lens with a dynamic light scattering device. Exp Eye Res. 2002 Jan;74(1):93-102. doi: 10.1006/exer.2001.1106.

    PMID: 11878822BACKGROUND
  • Benedek GB, Chylack LT Jr, Libondi T, Magnante P, Pennett M. Quantitative detection of the molecular changes associated with early cataractogenesis in the living human lens using quasielastic light scattering. Curr Eye Res. 1987 Dec;6(12):1421-32. doi: 10.3109/02713688709044506.

    PMID: 3427992BACKGROUND
  • Thurston GM, Hayden DL, Burrows P, Clark JI, Taret VG, Kandel J, Courogen M, Peetermans JA, Bowen MS, Miller D, Sullivan KM, Storb R, Stern H, Benedek GB. Quasielastic light scattering study of the living human lens as a function of age. Curr Eye Res. 1997 Mar;16(3):197-207. doi: 10.1076/ceyr.16.3.197.15410.

    PMID: 9088735BACKGROUND

MeSH Terms

Conditions

Corneal DiseasesCorneal Opacity

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

December 9, 2002

First Posted

December 10, 2002

Study Start

December 1, 2002

Study Completion

September 1, 2005

Last Updated

March 4, 2008

Record last verified: 2005-09

Locations