TearLab Refractive Surgery Dry Eye Study

TearLab

Status: Completed

Conditions: Dry Eye Syndromes

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT01176045

TP00087

Details and patient eligibility

About

The primary objective of this study is to determine how pre & post-operative tear osmolarity levels relate to rates of dry eye symptoms related to refractive surgery and if differences exist in patients who are pre-treated with ocular lubricants vs. those treated only post-operatively.

Full description

Dry eye disease is a common and major source of disability, whether occurring as a primary disorder or as a component of other diseases and its onset may be triggered or modified by exposure to systemic drugs, contact lens wear, ocular surgery and adverse environmental and work conditions. The development of a reliable, highly sensitive and specific test for the clinical diagnosis of dry eye is a major unmet clinical need, particularly to differentiate it from common conditions such as ocular allergy which exhibit similar presenting symptoms. Tear hyper-osmolarity is central to the dry eye disease process and the measurement of tear osmolarity could serve not only as a highly accurate diagnostic test but also as a measure of disease severity and a means to monitor treatment efficacy.

Recently, there have been reports in the literature regarding dry eye disease; both early and chronic following refractive surgery, with many cases potentially being previously inadvertently undiagnosed dry eye disease.

Enrollment: 128 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female, twenty-one years of age or older.
• Confirmed diagnosis of refractive error receiving LASIK surgery.
• Patient motivation and willingness to cooperate with the investigator and ability to return for all visits during the study.

Exclusion criteria

• Compromised cognitive ability that may be expected to interfere with study compliance.
• Clinically significant eyelid deformity or eyelid movement disorder that is caused by conditions such as notch deformity, incomplete lid closure, entropion, ectropion, hordeola or chalazia.
• Previous ocular disease leaving sequelae or requiring current topical eye therapy other than for DED, including, but not limited to: active corneal or conjunctival infection of the eye and ocular surface scarring.
• Active ocular allergy
• Patients requiring punctual occlusion prior to surgery
• Patients requiring cyclosporine ophthalmic emulsion prior to surgery
• Standard exclusion criteria for refractive surgery used by each surgeon.
• Known hypersensitivity to any of the agents used in testing
• Ophthalmologic drop use within 2 hours of any visit

Trial design

128 participants in 2 patient groups

Pre-surgical treatment

Description:

Patients who are pre \& post-surgical treated with ocular lubricants.

Non-presurgical treatment

Description:

Patients who are only post-surgical treated with ocular lubricants