Controlled Adverse Environment: A Pilot Study to Evaluate Tear Film Stability and Tear Evaporation
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Purpose
Dry eye and ocular surface disease account for a lot of morbidity and socio-economic burden in Asia and the rest of the world. This is a small pilot study to evaluate tear function under different conditions of humidity and temperature. This data will be useful for designing future trials in ocular surface and dry eye. The data will likely be used to propose a larger national funded project involving clinical trials. This study involves collaboration between engineers, ocular surface clinicians as well as specialists from the defence science organisation. When successfully completed, the project will increase the capability of Singapore Eye Research Institute and Singapore National Eye Centre to support future industry and academic research in the ocular surface.
| Condition | Intervention |
|---|---|
|
Environmental Exposure |
Procedure: temperature and humidity |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Controlled Adverse Environment: A Pilot Study to Evaluate Tear Film Stability and Tear Evaporation |
- Tear Evaporation Rate [ Time Frame: 20 minutes after the required temperature and humidity in the chamber is achieved ] [ Designated as safety issue: No ]The rate of tear evaporation is measured by the use of ocular thermography. For each subject,his/her ocular surface temperature will be recorded twice, one for each eye. The subject at first rests his/her chin on a chin rest, with his/her forehead lean against a metal frame (which is part of the chin rest). Then the recording starts lasting approximately 20seconds for each eye. While recording, the subject needs to look straight into the lens, but can blink naturally. After this, the recording data will be analyzed to derive the evaporation rate using a mathematical model.
- Tear Film Break up Time [ Time Frame: 20 minutes after the required temperature and humidity in the chamber is achieved ] [ Designated as safety issue: No ]After instillation of fluorescein, the participant will then be asked to open the eyes, look ahead at the observer's forehead and not blink for as long as possible. The break up time is defined as the time between the lid opening and the first appearance of any dry spot on the cornea. The participant will be requested to close his eyes for few seconds and the procedure will be repeated for the left eye.
| Enrollment: | 10 |
| Study Start Date: | January 2012 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: temperature and humidity
The volunteer is exposed to a controlled environment with a chamber setting of:
|
Procedure: temperature and humidity
The volunteer is exposed to a controlled environment with a chamber setting of:
After an adaptation period of at least 20 minutes, participants underwent measurements of tear evaporation and tear film break up time. After collection of data, the chamber settings were adjusted to the next condition. |
Show Detailed Description Eligibility| Ages Eligible for Study: | 21 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- must have undergone screening examination
Exclusion Criteria:
- unable to go to the DSO laboratory or undergo any of the study procedures
Contacts and Locations| Singapore | |
| Singapore Eye Research Institute | |
| Singapore, Singapore, 168751 | |
| Principal Investigator: | Andrea Petznick, PhD | Singapore Eye Research Institute |
More Information
Publications:
| Responsible Party: | Andrea Petznick, PhD, Postdoctoral Research Fellow, Singapore Eye Research Institute |
| ClinicalTrials.gov Identifier: | NCT01448356 History of Changes |
| Other Study ID Numbers: | R857/52/2011, 2011/197/A |
| Study First Received: | October 4, 2011 |
| Results First Received: | July 17, 2012 |
| Last Updated: | November 14, 2012 |
| Health Authority: | Singapore: Health Sciences Authority |
Keywords provided by Singapore Eye Research Institute:
|
Controlled adverse chamber tear film stability tear film evaporation |
tear film break up time humidity temperature |
ClinicalTrials.gov processed this record on May 16, 2013