Corneal DiseasesNCT00050466
Dynamic Light Scattering and Keratoscopy for Corneal Examination
An observational study of Corneal Diseases, run by National Eye Institute (NEI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Corneal Diseases
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2002to Sep 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- To be eligible, participants must not satisfy the criterion below:
- Individuals who cannot cooperate or keep still for the DLS measurements.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Eye Institute (NEI)
Bethesda, Maryland, 20892
About this study
Official title: A Pilot Study Using the Dynamic Light Scattering Device (DLS) Combined With Keratoscopy on the Cornea in Vivo
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.
Read the detailed description
Corneal disease and injuries are the leading cause of visits to eye care clinics in the US today. These diseases are also some of the most painful eye disorders. Two important areas for research on the cornea are 1) to explore and understand the molecular basis of corneal transparency and 2) to analyze the molecular nature of corneal inflammation and wound healing. We have developed a new clinical device to understand molecular changes that occur in the lens, called Dynamic Light Scattering (DLS) device. Studies have shown its potential in the detection of the earliest changes occurring in the cataract, and have also shown good test retest reproducibility of the system. We now would like to apply this technique to study changes that occur in corneal opacification. In this pilot project, we would like to study the normal cornea in young and older persons (volunteers) as well as cloudy, opaque corneas. This will allow us to determine if useful data can be obtained, and if so, lead to further studies in various corneal disorders caused by trauma, infections, and dystrophies, as well as those caused by systemic or inherited disorders.
- Conditions
- Corneal Diseases
- Keywords
- Normal Volunteers, Dynamic Light Scattering (DLS), Corneal Opacities, Cornea, Transparency, Vision
- Medical subject headings
- Corneal Diseases, Corneal Opacity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startDec 2002
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Corneal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00050466
- Sponsor's protocol ID
- 030012
- Other IDs
- 03-EI-0012
- Status last verified
- Sep 2005
- First submitted
- 9 Dec 2002
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
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.
PubMed 11878822Benedek 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.
PubMed 3427992Thurston 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.
PubMed 9088735
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Using the Dynamic Light Scattering Device (DLS) Combined With Keratoscopy on the Cornea in Vivo
- ClinicalTrials.gov ID
- NCT00050466
- Acronym / sponsor ID
- 030012
- Conditions
- Corneal Diseases
- Keywords
- Normal Volunteers, Dynamic Light Scattering (DLS), Corneal Opacities, Cornea, Transparency, Vision
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- Dec 2002
- Study completion
- Sep 2005
- First posted
- 10 Dec 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Corneal disease and injuries are the leading cause of visits to eye care clinics in the US today. These diseases are also some of the most painful eye disorders. Two important areas for research on the cornea are 1) to explore and understand the molecular basis of corneal transparency and 2) to analyze the molecular nature of corneal inflammation and wound healing. We have developed a new clinical device to understand molecular changes that occur in the lens, called Dynamic Light Scattering (DLS) device. Studies have shown its potential in the detection of the earliest changes occurring in the cataract, and have also shown good test retest reproducibility of the system. We now would like to apply this technique to study changes that occur in corneal opacification. In this pilot project, we would like to study the normal cornea in young and older persons (volunteers) as well as cloudy, opaque corneas. This will allow us to determine if useful data can be obtained, and if so, lead to further studies in various corneal disorders caused by trauma, infections, and dystrophies, as well as those caused by systemic or inherited disorders.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals greater than or equal to 18 years of age.
- Control subjects must have normal, clear corneas as determined by slit lamp biomicroscopy and central corneal thickness less than 0.55 mm centrally.
- Patients with corneal clouding and opacification.
Key exclusion criteria (2 listed)
- Individuals who cannot cooperate or keep still for the DLS measurements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 11878822Datiles 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.
- Background: PubMed 3427992Benedek 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.
- Background: PubMed 9088735Thurston 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.
Related trials for Corneal Diseases
RecruitingPhase 2
An Open-Label Phase 2 Study of N-Acetyl-D-Mannosamine (ManNAc) in Subjects With Podocyte Diseases
Focal Segmental Glomerulosclerosis, Minimal Change Disease
Not yet recruitingObservational study
Corneal Biomechanics and Stromal Tissue Characteristics in Patients Undergoing SMILE
Myopia
Not yet recruitingPhase 4
Evaluation of the Impact of Oral Ivermectin on Musca Sorbens Flies, Putative Vector of Trachoma
Survival of Flies Developing in Faecal Samples
Active, not recruitingPhase 2
Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity
Lymphoproliferative Disorder, HHV-8
Not yet recruitingPhase 1
A Clinical Study to Evaluate the Safety and Effectiveness of MSCohi-O Lens in the Treatment of Immune-related Ocular Surface Diseases.
Keratitis, Autoimmunity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corneal Diseases, run by National Eye Institute (NEI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00050466, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.