Meibomian Gland DysfunctionNCT05713981
The Impact of Dry Eye Syndrome on Metrics of Low Contrast Vision Before and After Meibomian Gland Expression
A study testing Meibomian gland (MG) expression in people with Meibomian Gland Dysfunction, run by University of the Incarnate Word at 1 site in United States.
Trial summary
The study aims to determine the impact of Meibomian Gland Dysfunction (MGD) dry eye on low contrast black/white (luminance) and cone color sensitivity performance and improvement in these functions after in-house non-invasive Meibomian gland (MG) expression. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Meibomian Gland Dysfunction
- What is being tested?
- Meibomian gland (MG) expression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 8 Jun 2023
- Phase
- Interventional
- 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
Who may be able to join
- Individuals over the age of 18 years
- Healthy individuals with reported symptoms of dry eye such as burning, stinging, fluctuating vision, inappropriate tearing, and feelings of grittiness particularly with prolonged near work
Who cannot join
- Under the age of 18
- Individuals currently using prescription eye medications for dry eye / MGD / inflammation / Infections or any other treatments.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of the Incarnate Word Rosenberg School of Optometry
San Antonio, Texas, 78229
About this study
Official title: The Impact of Dry Eye Syndrome on Novel Metrics of Low Contrast Vision Before and After Therapeutic Meibomian Gland Expression
The study aims to determine the impact of Meibomian Gland Dysfunction (MGD) dry eye on low contrast black/white (luminance) and cone color sensitivity performance and improvement in these functions after in-house non-invasive Meibomian gland (MG) expression.
Read the detailed description
This study offers possible benefits from gland expression to patients and subjects in terms of clinical measurements and care associated with meibomian gland dysfunction impacting all age ranges. Prior studies show that these interventions improve dry eye symptoms with intent to improve vision, low contrast color, and B/W vision after intervention in this study.
- Conditions
- Meibomian Gland Dysfunction
- Being tested
- Meibomian gland (MG) expression
- Medical subject headings
- Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meibomian gland (MG) expressionProcedure or surgery
The procedure is performed with a sterile cotton tip applicator once in the upper and lower eyelids of the subject's choosing.
| Study group | Role | What they receive |
|---|---|---|
| non-invasive Meibomian gland (MG) expression | Experimental | Baseline testing of visual acuity, contrast sensitivity, color vision, and Innova, Inc. cone and B/W low contrast vision will be measured.
The intervention will be standard clinical expression of Meibomian superior and inferior glands (MG) using a sterile cotton tip applicator to apply gentle pressure in a rolling motion in the direction of the MGs along the upper and lower eyelid margins to allow oil secretion of the tested eye. One drop of sterile saline will be instilled following the intervention to remove debris. The subject's visual acuity, contrast sensitivity, color vision, and Innova, Inc. cone and B/W low contrast vision will be measured before and after this intervention. Receives: Procedure: Meibomian gland (MG) expression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cone Contrast Sensitivity on the Cone Contrast Test (CCT, Innova Systems, Inc.)
This computer test measures the lowest contrast (contrast sensitivity) to see red, green and blue cone specific letters.
Measured: This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
Change in Response Time on Cone Contrast Test (CCT, Innova Systems, Inc.)
This computer test measures average response time in seconds to see red, green and blue low contrast letters.
Measured: This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
Secondary outcomes (6)
Change in Black White Contrast Sensitivity (Innova Systems, Inc)
This computer test measures the lowest contrast (contrast sensitivity) to see black/white letters.
Measured: This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
Change in Response Time on Black White Contrast Sensitivity Test (Innova Systems, Inc) Response Time
This computer test measures average response time in seconds to see low contrast black/white letters
Measured: This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
Change in Visual Acuity Test at Low Contrast (Innova Systems, Inc)
This computer test measures the smallest low contrast letters which can be seen.
Measured: This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
Change in Response Time on Visual Acuity Test at Low Contrast (Innova Systems, Inc)
This computer test measures average response time in seconds to see low contrast visual acuity letters
Measured: This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
Change in Sensitivity on Cone Contrast Color Naming test (CCNT)
This computer test measures the lowest contrast (contrast sensitivity) to see red, green, blue and grey letters.
Measured: This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
Change in Color Naming Accuracy on Cone Contrast Color Naming test (CCNT)
This computer test measures the accuracy of naming (number correct) low contrast red, green, blue and grey letters.
Measured: This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start1 Mar 2023
- Primary completion8 Jun 2023
- Study completion8 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Meibomian Gland DysfunctionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Incarnate Word
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JEFFREY CARL RABIN, University of the Incarnate Word
- Investigators
- Jeffery Rabin, OD, PhD, Study chair, University of the Incarnate Word
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713981
- Sponsor's protocol ID
- 2022-1283-EXP
- Status last verified
- Jun 2023
- First submitted
- 29 Dec 2022
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Share IPD will facilitate data analysis and understanding for current and future research. We will share outcome and results and potentially present to local, national, and international faculty during conferences.
Publications
Gao Y, Liu R, Liu Y, Ma B, Yang T, Hu C, Qi H. Optical quality in patients with dry eye before and after treatment. Clin Exp Optom. 2021 Jan;104(1):101-106. doi: 10.1111/cxo.13111.
PubMed 32618024Szczotka-Flynn LB, Maguire MG, Ying GS, Lin MC, Bunya VY, Dana R, Asbell PA; Dry Eye Assessment and Management (DREAM) Study Research Group. Impact of Dry Eye on Visual Acuity and Contrast Sensitivity: Dry Eye Assessment and Management Study. Optom Vis Sci. 2019 Jun;96(6):387-396. doi: 10.1097/OPX.0000000000001387.
PubMed 31116166Narayanan S, Miller WL, Prager TC, Jackson JA, Leach NE, McDermott AM, Christensen MT, Bergmanson JP. The diagnosis and characteristics of moderate dry eye in non-contact lens wearers. Eye Contact Lens. 2005 May;31(3):96-104. doi: 10.1097/01.icl.0000140907.45705.e2.
PubMed 15894874Thulasi P, Djalilian AR. Update in Current Diagnostics and Therapeutics of Dry Eye Disease. Ophthalmology. 2017 Nov;124(11S):S27-S33. doi: 10.1016/j.ophtha.2017.07.022.
PubMed 29055359Yeh TN, Lin MC. Meibomian Gland Contrast Sensitivity and Specificity in the Diagnosis of Lipid-deficient Dry Eye: A Pilot Study. Optom Vis Sci. 2021 Feb 1;98(2):121-126. doi: 10.1097/OPX.0000000000001636.
PubMed 33534375
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Dry Eye Syndrome on Novel Metrics of Low Contrast Vision Before and After Therapeutic Meibomian Gland Expression
- ClinicalTrials.gov ID
- NCT05713981
- Acronym / sponsor ID
- 2022-1283-EXP
- Conditions
- Meibomian Gland Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of the Incarnate WordUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 8 Jun 2023 (actual)
- Study completion
- 8 Jun 2023 (actual)
- First posted
- 6 Feb 2023 (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 study aims to determine the impact of Meibomian Gland Dysfunction (MGD) dry eye on low contrast black/white (luminance) and cone color sensitivity performance and improvement in these functions after in-house non-invasive Meibomian gland (MG) expression.
Detailed description
This study offers possible benefits from gland expression to patients and subjects in terms of clinical measurements and care associated with meibomian gland dysfunction impacting all age ranges. Prior studies show that these interventions improve dry eye symptoms with intent to improve vision, low contrast color, and B/W vision after intervention in this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non-invasive Meibomian gland (MG) expression | Experimental | Procedure: Meibomian gland (MG) expressionBaseline testing of visual acuity, contrast sensitivity, color vision, and Innova, Inc. cone and B/W low contrast vision will be measured. The intervention will be standard clinical expression of Meibomian superior and inferior glands (MG) using a sterile cotton tip applicator to apply gentle pressure in a rolling motion in the direction of the MGs along the upper and lower eyelid margins to allow oil secretion of the tested eye. One drop of sterile saline will be instilled following the intervention to remove debris. The subject's visual acuity, contrast sensitivity, color vision, and Innova, Inc. cone and B/W low contrast vision will be measured before and after this intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals over the age of 18 years
- Healthy individuals with reported symptoms of dry eye such as burning, stinging, fluctuating vision, inappropriate tearing, and feelings of grittiness particularly with prolonged near work
Key exclusion criteria (2 listed)
- Under the age of 18
- Individuals currently using prescription eye medications for dry eye / MGD / inflammation / Infections or any other treatments.
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 |
|---|---|---|
| Meibomian gland (MG) expressionThe procedure is performed with a sterile cotton tip applicator once in the upper and lower eyelids of the subject's choosing. | Procedure or surgery | non-invasive Meibomian gland (MG) expression |
Primary outcome
Change in Cone Contrast Sensitivity on the Cone Contrast Test (CCT, Innova Systems, Inc.)
Time frame: This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
This computer test measures the lowest contrast (contrast sensitivity) to see red, green and blue cone specific letters.
Change in Response Time on Cone Contrast Test (CCT, Innova Systems, Inc.)
Time frame: This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
This computer test measures average response time in seconds to see red, green and blue low contrast letters.
6 secondary outcomes
Change in Black White Contrast Sensitivity (Innova Systems, Inc)
Time frame: This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
Change in Response Time on Black White Contrast Sensitivity Test (Innova Systems, Inc) Response Time
Time frame: This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
Change in Visual Acuity Test at Low Contrast (Innova Systems, Inc)
Time frame: This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
Change in Response Time on Visual Acuity Test at Low Contrast (Innova Systems, Inc)
Time frame: This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
Change in Sensitivity on Cone Contrast Color Naming test (CCNT)
Time frame: This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
Change in Color Naming Accuracy on Cone Contrast Color Naming test (CCNT)
Time frame: This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
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 26 Jun 2023.
- Background: PubMed 32618024Gao Y, Liu R, Liu Y, Ma B, Yang T, Hu C, Qi H. Optical quality in patients with dry eye before and after treatment. Clin Exp Optom. 2021 Jan;104(1):101-106. doi: 10.1111/cxo.13111.
- Background: PubMed 31116166Szczotka-Flynn LB, Maguire MG, Ying GS, Lin MC, Bunya VY, Dana R, Asbell PA; Dry Eye Assessment and Management (DREAM) Study Research Group. Impact of Dry Eye on Visual Acuity and Contrast Sensitivity: Dry Eye Assessment and Management Study. Optom Vis Sci. 2019 Jun;96(6):387-396. doi: 10.1097/OPX.0000000000001387.
- Background: PubMed 15894874Narayanan S, Miller WL, Prager TC, Jackson JA, Leach NE, McDermott AM, Christensen MT, Bergmanson JP. The diagnosis and characteristics of moderate dry eye in non-contact lens wearers. Eye Contact Lens. 2005 May;31(3):96-104. doi: 10.1097/01.icl.0000140907.45705.e2.
- Background: PubMed 29055359Thulasi P, Djalilian AR. Update in Current Diagnostics and Therapeutics of Dry Eye Disease. Ophthalmology. 2017 Nov;124(11S):S27-S33. doi: 10.1016/j.ophtha.2017.07.022.
- Background: PubMed 33534375Yeh TN, Lin MC. Meibomian Gland Contrast Sensitivity and Specificity in the Diagnosis of Lipid-deficient Dry Eye: A Pilot Study. Optom Vis Sci. 2021 Feb 1;98(2):121-126. doi: 10.1097/OPX.0000000000001636.
- Individual participant dataSharing planned: Yes. Share IPD will facilitate data analysis and understanding for current and future research. We will share outcome and results and potentially present to local, national, and international faculty during conferences.
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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.
Jeffery Rabin, OD, PhD study chair
University of the Incarnate Word
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meibomian gland (MG) expression in people with Meibomian Gland Dysfunction, run by University of the Incarnate Word 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 2 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 26 Jun 2023. 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?
Change in Cone Contrast Sensitivity on the Cone Contrast Test (CCT, Innova Systems, Inc.) (time frame: This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05713981, which also lists 5 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 26 Jun 2023.