Hypotony OcularNCT04023123
Anterior Corneal Striae in Hypotony
An observational study of Hypotony Ocular and Cornea Folds and Rupture of Bowman's Membrane Both Eyes, run by Duke University at 1 site in United States.
Trial summary
The goal of this is to evaluate the biomechanical properties of hypotonous eyes with vertical anterior corneal striae and/or hypotony maculopathy compared to hypotonous eyes without striae. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypotony Ocular, Cornea Folds and Rupture of Bowman's Membrane Both Eyes, Maculopathy
- What is being tested?
- Ophthalmic imaging
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2019to 23 Mar 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects >= 18 years of age with a history of glaucoma and glaucoma surgery
Who may be able to join
- Subjects >= 18 years of age
- History of glaucoma
- History of glaucoma surgery
- Intraocular pressure of equal to or less than 10 mm Hg by goldmann applanation
Who cannot join
- Coexisting ocular disease that may affect ocular biomechanics, including macular disease, corneal transplant, and uveitis
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27705
About this study
Official title: The Clinical Significance of Anterior Corneal Striae in Hypotony
The goal of this is to evaluate the biomechanical properties of hypotonous eyes with vertical anterior corneal striae and/or hypotony maculopathy compared to hypotonous eyes without striae.
- Being tested
- Ophthalmic imaging
- Medical subject headings
- Ocular Hypotension, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ophthalmic imagingOther
Optical coherence tomography Topography Ocular Response Analyzer Optical Biometry Slit lamp photos
| Study group | Role | What they receive |
|---|---|---|
| Anterior Cornea Striae | Eyes with anterior cornea striae present Receives: Other: Ophthalmic imaging | |
| Hypotony Maculopathy | Eyes with hypotony maculopathy present Receives: Other: Ophthalmic imaging | |
| Hypotony only | Eyes with intraocular pressure less than 10 without cornea striae and/or maculopathy Receives: Other: Ophthalmic imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal hysteresis
Difference in postoperative corneal hysteresis (measured in mm Hg) by Ocular Response Analyzer, between study arms
Measured: Baseline
Incidence of anterior corneal striae
Frequency of occurrence among all enrolled hypotonous eyes
Measured: Baseline
Incidence of hypotony maculopathy
Frequency of occurrence among all enrolled hypotonous eyes
Measured: Baseline
Secondary outcomes (4)
Axial length
Difference in postoperative axial length between study arms
Measured: Baseline
Corneal thickness
Difference in postoperative corneal thickness between study arms
Measured: Baseline
Corneal curvature
Difference in postoperative diopters of steepest cornea axis, flattest cornea axis and astigmatism between study arms
Measured: Baseline
Corneal resistance factor
Difference in postoperative corneal resistance factor between study arms
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start17 Sep 2019
- Primary completion23 Mar 2020
- Study completion23 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotony OcularStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leon Herndon, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023123
- Sponsor's protocol ID
- Pro00102744
- Status last verified
- Jun 2019
- First submitted
- 11 Jul 2019
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Significance of Anterior Corneal Striae in Hypotony
- ClinicalTrials.gov ID
- NCT04023123
- Acronym / sponsor ID
- Pro00102744
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 23 Mar 2020 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 17 Jul 2019 (actual)
- 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.
The goal of this is to evaluate the biomechanical properties of hypotonous eyes with vertical anterior corneal striae and/or hypotony maculopathy compared to hypotonous eyes without striae.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anterior Cornea Striae | – | Other: Ophthalmic imagingEyes with anterior cornea striae present |
| Hypotony Maculopathy | – | Other: Ophthalmic imagingEyes with hypotony maculopathy present |
| Hypotony only | – | Other: Ophthalmic imagingEyes with intraocular pressure less than 10 without cornea striae and/or maculopathy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects >= 18 years of age with a history of glaucoma and glaucoma surgery
Key inclusion criteria (4 listed)
- Subjects >= 18 years of age
- History of glaucoma
- History of glaucoma surgery
- Intraocular pressure of equal to or less than 10 mm Hg by goldmann applanation
Key exclusion criteria (1 listed)
- Coexisting ocular disease that may affect ocular biomechanics, including macular disease, corneal transplant, and uveitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ophthalmic imagingOptical coherence tomography Topography Ocular Response Analyzer Optical Biometry Slit lamp photos | Other | Anterior Cornea Striae, Hypotony Maculopathy, Hypotony only |
Primary outcome
Corneal hysteresis
Time frame: Baseline
Difference in postoperative corneal hysteresis (measured in mm Hg) by Ocular Response Analyzer, between study arms
Incidence of anterior corneal striae
Time frame: Baseline
Frequency of occurrence among all enrolled hypotonous eyes
Incidence of hypotony maculopathy
Time frame: Baseline
Frequency of occurrence among all enrolled hypotonous eyes
4 secondary outcomes
Axial length
Time frame: Baseline
Corneal thickness
Time frame: Baseline
Corneal curvature
Time frame: Baseline
Corneal resistance factor
Time frame: Baseline
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 5 May 2020.
- Individual participant dataSharing planned: No
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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.
Leon Herndon, MD principal investigator
Duke University
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 Hypotony Ocular and Cornea Folds and Rupture of Bowman's Membrane Both Eyes, run by Duke University 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 4 inclusion and 1 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 5 May 2020. 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.
What does the primary outcome measure?
Corneal hysteresis (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 May 2020.