An observational study in Dry Eye Syndromes, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-15.
Sponsored by Johns Hopkins University · Observational
To assess the reading function impairment in patients with dry eye and to assess the effects of reading on the ocular surface.
This study is being done to understand how reading is affected in people with dry eye in comparison with healthy controls and what effect reading has on the ocular surface in patients with dry eye.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 200 is above the median of 90 across 171 observational studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with known dry eye as well as normal healthy control subjects with no ocular surface diseases will be recruited from the Ocular Surface Diseases and Dry Eye Clinic as well as Glaucoma Clinic of the Wilmer Eye Institute.
Exclusion Criteria:
The patients with Sjogren Syndrome related or non-Sjogren Syndrome related dry eye. The participants will be asked some questions. Before and after reading a text silently in 30 minutes "30 minutes sustained reading", a detailed dry eye exam will be performed.
Other: 30 minutes sustained reading · Other: Dry eye exam
The patients without dry eye. The participants will be asked some questions. Before and after reading a text silently in 30 minutes "30 minutes sustained reading", a detailed dry eye exam will be performed.
Other: 30 minutes sustained reading · Other: Dry eye exam
The participants will be given a text to read silently in 30 minutes.
Tear break-up time, tear collection, osmolarity, Schirmer test, corneal and conjunctival staining.
Sustained Silent Reading Speed
Time frame: 30 minutes
Change in Total Ocular Staining Score (OSS)
Ocular staining score (OSS) is sum of the corneal and conjuctival staining scores with a total possible maximum score of 12 for each eye. Corneal staining is graded with a maximum possible fluorescein score of 6 for each cornea (the punctate epithelial erosions grade between 0-3 plus any extra points for modifiers up to 3). Nasal and temporal conjunctiva are graded separately with a score range between 0 and 3 for each area after instillation of lissamine green. An abnormal OSS is defined as being a total score of 3 or more.
Time frame: Before and after 30 minutes reading
Change in Tear Osmolarity
Time frame: Before and after 30 minutes reading
Change in Visual Acuity
Time frame: 30 minutes
Cytokines
Identification of various inflammatory cytokines in tear film of dry eye patients comparing to controls.
Time frame: Tear samples were collected on the day of the exam. The samples were frozen to be assayed upon completion of the study.
| Milestone | Dry Eye | Controls |
|---|---|---|
| Started | 167 | 33 |
| Completed | 167 | 32 |
| Not completed | 0 | 1 |
| words/minute | Dry Eye | Controls |
|---|---|---|
| Sustained Silent Reading Speed | 248.4 ± 79.5 | 270.3 ± 75.3 |
Ocular staining score (OSS) is sum of the corneal and conjuctival staining scores with a total possible maximum score of 12 for each eye. Corneal staining is graded with a maximum possible fluorescein score of 6 for each cornea (the punctate epithelial erosions grade between 0-3 plus any extra points for modifiers up to 3). Nasal and temporal conjunctiva are graded separately with a score range between 0 and 3 for each area after instillation of lissamine green. An abnormal OSS is defined as being a total score of 3 or more.
| units on a scale | Dry Eye | Controls |
|---|---|---|
| Change in Total Ocular Staining Score (OSS) | 1.5 ± 1.4 | 1.1 ± 1.2 |
| mOsm/L | Dry Eye | Controls |
|---|---|---|
| Change in Tear Osmolarity | 2.7 ± 12.3 | 1.8 ± 10.9 |
| logMAR | Dry Eye | Controls |
|---|---|---|
| Change in Visual Acuity | 0.02 ± 0.07 | 0.02 ± 0.09 |
Identification of various inflammatory cytokines in tear film of dry eye patients comparing to controls.
| pg/mL | Dry Eye | Controls |
|---|---|---|
| IFNg | 99.79 ± 16.81 | 150.10 ± 30.29 |
| TNFa | 131.16 ± 54.63 | 107.53 ± 25.30 |
| IL6 | 130.78 ± 39.65 | 69.64 ± 13.40 |
| IL17A | 176.08 ± 28.39 | 200.00 ± 41.42 |
| IL1b | 27.40 ± 5.09 | 27.87 ± 6.47 |
| IL8 | 903.91 ± 268.02 | 157.58 ± 32.39 |
| IL10 | 211.69 ± 30.37 | 304.29 ± 55.01 |
| IL12p70 | 70.89 ± 10.06 | 131.32 ± 28.59 |
Collected over Started with the first patient enrollment on 8/7/2013 until the last patient enrollment on 11/5/2015.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dry Eye | — | 0/167 (0%) | 0/167 (0%) |
| Controls | — | 0/33 (0%) | 0/33 (0%) |
| Age, Continuous(years) | Dry Eye | Controls | Total |
|---|---|---|---|
| Mean | 64.1 ± 8.7 | 61.4 ± 8.7 | 63.7 ± 8.3 |
| Sex: Female, Male(Participants) | Dry Eye | Controls | Total |
|---|---|---|---|
| Female | 122 | 19 | 141 |
| Male | 45 | 14 | 59 |
| Ethnicity (NIH/OMB)(Participants) | Dry Eye | Controls | Total |
|---|---|---|---|
| Hispanic or Latino | 7 | 1 | 8 |
| Not Hispanic or Latino | 160 | 32 | 192 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Dry Eye | Controls | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 2 |
| Asian | 5 | 1 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 17 | 6 | 23 |
| White | 139 | 24 | 163 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 5 | 1 | 6 |
| Region of Enrollment(participants) | Dry Eye | Controls | Total |
|---|---|---|---|
| United States | 167 | 33 | 200 |
| Baseline Visual Acuity, logMAR(logMAR) | Dry Eye | Controls | Total |
|---|---|---|---|
| Mean | -0.04 ± 0.11 | -0.03 ± 0.10 | -0.038 ± 0.11 |
| Baseline Osmolarity(mOsm/L) | Dry Eye | Controls | Total |
|---|---|---|---|
| Mean | 312 ± 28 | 306 ± 10 | 311 ± 26 |
| Baseline total OSS score(scores on a scale of 0 to 12) | Dry Eye | Controls | Total |
|---|---|---|---|
| Mean | 4.9 ± 3.3 | 0.9 ± 0.9 | 4.3 ± 3.4 |
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