Prevalence of Dry Eyes in Diabetics Compared to Non Diabetics

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01450787

Enrollment

Registered

2011-10-12

Start date

2012-01-31

Completion date

2012-06-30

Last updated

2013-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eyes

Keywords

dry eyes, diabetes

Brief summary

The purpose is to compare the prevalence of dry eyes in diabetics and non diabetics. This might help identify a group of patients at greater risk for dry eye complications. Diabetics have been shown to have poor ocular surface healing and might benefit from dry eye therapy earlier if they are shown to be at greater risk for dry eyes.

Detailed description

Dry eye disease is one of the most common eye problems seen in ophthalmology. Diabetics are at high risk for multiple eye problems, including retinopathy and glaucoma. They also have been shown to have poor ocular surface healing. I would like to evaluate the prevalence of dry eye disease in diabetics to see if they are also at greater risk for the known complications of dry eye disease. If so, they might benefit from early intervention.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* 50 patients with diabetes, 25 without diabetes over the age of 40

Exclusion criteria

* current use of glaucoma drops or currently within the postoperative period from eye surgery

Design outcomes

Primary

Measure	Time frame	Description
Conjunctival Staining Score	at the time of the evaluation	Conjunctival staining with lissamine green dye is measured at the time of the evaluation on a scale from 0 to 5 using the oxford scoring system, with 5 being the most severe staining.

Secondary

Measure	Time frame	Description
Tear Film Osmolarity	at the time of the exam	The tear film osmolarity is measured at the time of the exam.

Other

Measure	Time frame	Description
OSDI Score	at the time of the exam	The ocular surface disease index survey in completed at the time of the exam. This scale ranges from 0 to 100 higher scores representing greater disability.
Schirmer Score	at the time of the exam	The schirmer tear production test with anesthesia is completed at the time of the exam in mm of tear film absorption on the test strip after five minutes. Higher scores represent greater tear production.
Tear Break-up Time	at the time of the exam	The tear break-up time with fluorescein solution is measured at the time of the exam in seconds.
Corneal Staining	at the time of the exam	Corneal staining with fluorescein solution is graded at the time of the exam on a scale of 0 to 5 using the oxford scoring system with 5 being the most severe staining.

Countries

United States

Participant flow

Recruitment details

Subjects were enrolled randomly. Consecutive patients in a private ophthalmology clinic that met inclusion criteria were asked to participate at the time of an already scheduled exam. The non-diabetic group recruitment stopped once the target number of subjects enrolled. The diabetic group recruitment continued until the study was terminated.

Pre-assignment details

Being that there was no intervention and the study only involved taking measurements at the time of the exam, there was no transition required. Any eligible patient that was willing to participate was included. Consecutive diabetic patients and consecutive non-diabetic patients that met criteria were offered the opportunity to enroll.

Participants by arm

Arm	Count
Diabetics diabetics over age 40	38
Non Diabetics non diabetics over age 40	25
Total	63

Baseline characteristics

Characteristic	Diabetics	Non Diabetics	Total
Age, Customized	38 participants	25 participants	63 participants
Region of Enrollment United States	38 participants	25 participants	63 participants
Sex: Female, Male Female	22 Participants	21 Participants	43 Participants
Sex: Female, Male Male	16 Participants	4 Participants	20 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 38	0 / 25
serious Total, serious adverse events	0 / 38	0 / 25

Outcome results

Primary

Conjunctival Staining Score

Conjunctival staining with lissamine green dye is measured at the time of the evaluation on a scale from 0 to 5 using the oxford scoring system, with 5 being the most severe staining.

Time frame: at the time of the evaluation

Population: There were 38 consecutive diabetics over 40 years of age and 25 consecutive non-diabetics over 40 years of age that qualified and agreed to enroll. A target of 25 non-diabetics was met. The target of 50 was not met as the study was stopped when the PI changed practices. By that time, 38 diabetics enrolled.

Arm	Measure	Value (MEAN)	Dispersion
Diabetics	Conjunctival Staining Score	2.72 units on a scale	Standard Error 0.16
Non Diabetics	Conjunctival Staining Score	2.19 units on a scale	Standard Error 0.19

Secondary