The major goal of this study is to develop a systematic and stepwise approach for dry eyes. First, it will be evaluated whether Tes glasses are a diagnostic tool for dry eye diseases. Second, it will be evaluated or it can make a distinction between…
ID
Source
Brief title
Condition
- Ocular infections, irritations and inflammations
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The evaporation rate, and the dew point, Sialic acid concentration, number of
goblet cells.
Secondary outcome
subjective extent to which the patient experiences symptoms (McMonnies
questionnaire, VAS scale), the Schirmer test.
Background summary
Dry eye is a frequent problem in the ophthalmic practice. The problem is
complex in nature. There are many diagnostic tests described, most tests,
however, do not provide insight into the dynamic nature of the tear film.
Because the diagnosis is made on history grounds therapeutic measures are not
optimal. In recent decades, there is a discrepancy between the physical -
chemical research of the tear film and its clinical applications. This study
added two parameters that may provide insight into the pathophysiology of dry
eye: Sialic acid concentration in tears and Tes Glasses (Tear Evaporation
Sensoring Spectacles). Tes glasses are modified spectacles that measure the
evaporation of tears. In this way we want to obtain a division between
evaporative and non - evaporative dry eye. The research design of the pathway
dry eyes a decision tree is developed into a systematic, progressive approach
to come from both groups dry eye patients
Study objective
The major goal of this study is to develop a systematic and stepwise approach
for dry eyes. First, it will be evaluated whether Tes glasses are a diagnostic
tool for dry eye diseases. Second, it will be evaluated or it can make a
distinction between evaporative and non evaporative problem dry eyes. Finally,
it is examined whether a decrease in sialic acid and a decrease in the number
of goblet cells is appropriate in those with a non-evaporative dry eye problem.
Study design
The research design consists of a prospective study in dry eye patients while
ensuring a diagnostic value of a new instrument is tested to determine the
evaporation speed of the tear film. For this, the sensitivity and specificity
of the glasses Tess is determined. With the Tes spectacles we will make a
distinction betweenevaporative and non-evaporative dry eyes.
In the group of subjects with dry eyes, a Sialic Acid concentration will be
announced in combination with a impression cytology of the Conjunctiva to
determine the number of goblet cells.
Study burden and risks
this is a no-risk trial. The instruments used, pose no danger to the patient.
H. Gerhardstraat 10
Zaandam 1502 CK
NL
H. Gerhardstraat 10
Zaandam 1502 CK
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria persons without dry eyes: age > 18 years, never have symptoms of dry eyes (scored at the Mcmonnies questionnaire) , Osmolarity < 308.
Inclusion criteria persons with dry eyes: age > 18 years, symptoms of dry eyes (scored on the Mcmonnies questionnairre), Osmolarity > 308.
Exclusion criteria
Exclusion criteria for persons with and without dry eye symptoms: eye surgery, including refractive and plastiv surgery, herpes simpex infections, allergic constituion, antiglaucoma therapy, contact lens wearers, visual acuity < 0.1, chemotherapy treatment.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL52184.048.15 |