## Protocol Section
### Identification Module
**NCT ID:** NCT01351779

**Brief Title:** The Effect of Body Posture on Intraocular Pressure in Progressive Glaucoma

**Official Title:** The Effect of Body Posture on Intraocular Pressure in Progressive Glaucoma

#### Organization Study ID Info
**ID:** 10-0844-A
#### Organization
**Class:** OTHER
**Full Name:** University of Toronto
### Status Module
#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2011-05-11

**Type:** ESTIMATED

**Last Update Submit Date:** 2011-05-09

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2012-05

**Type:** ESTIMATED

#### Start Date
**Date:** 2011-05

**Status Verified Date:** 2011-05

#### Study First Post Date
**Date:** 2011-05-11
**Type:** ESTIMATED
**Study First Submit Date:** 2011-05-09
**Study First Submit QC Date:** 2011-05-09
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Sensimed AG

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Toronto

#### Responsible Party

**Old Name Title:** Professor Graham Trope

**Old Organization:** University of Toronto

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Glaucoma is a condition where the optic nerve (the nerve responsible for sight) shows progressive damage with characteristic loss of visual field. Glaucoma is very commonly associated with raised pressure in the eye (intraocular pressure \[IOP\]). IOP has been shown to increase when lying down in normal subjects as well as patients with glaucoma. It is possible that this effect can make glaucoma worse. This study is designed to investigate the effect of body posture (particularly when sleeping) on the IOP fluctuation in the eye. Each patient will be required to attend for 2 separate 24 hour visits. On one visit the patient will be required to sleep flat and on the other visit at a 30° head up sleeping position. During this time the patient will be required to wear a soft contact lens (SENSIMED Triggerfish®) which has a special sensor on it that monitors the IOP continuously. The IOP measurements are wirelessly transmitted to a recorder.

### Conditions Module

**Conditions:**

- Glaucoma

**Keywords:**

- Intraocular pressure

- Contact lens sensor

- Optic disc hemorrhage

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients with primary open angle glaucoma identified to have an optic disc hemorrhage

**Label:** Progressive glaucoma

### Outcomes Module

#### Primary Outcomes

**Description:** The intraocular pressure will be continuously monitored with a wireless contact lens sensor device over a 24 hour period

**Measure:** Intraocular pressure changes that occur during sleep and with changes in body posture

**Time Frame:** 24 hours

#### Secondary Outcomes

**Description:** Patients will be monitored for contact lens related side effects or adverse effects that occur during the monitoring session.

**Measure:** Incidence of side effects or adverse effects that occur while subjects are wearing the contact lens device

**Time Frame:** 24 hours

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* signed informed consent
* diagnosis of primary open angle glaucoma (POAG) or normal tension glaucoma (NTG) that is progressing based on recent or recurrent optic disc hemorrhage
* age 18-85 years
* not more than 4 diopters of spherical equivalent or 2 diopters of cylinder equivalent in study eye
* stable anti-glaucoma treatment for 4 weeks before first session
* for women of childbearing potential, adequate contraception

Exclusion Criteria:

* unwilling or unable to sleep in a flat or 30 degrees head up position
* ocular surgery in previous 3 months
* corneal or conjunctival abnormality
* wear of full frame metallic glasses during monitoring session
* severe dry eye
* secondary forms of glaucoma
* allergy to corneal anaesthesia
* patients with contraindications for contact lens wear
* pregnancy and lactation
* patients unable to understand the character and individual consequences of the investigation
* simultaneous participation in other research

**Maximum Age:** 85 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Glaucoma clinic patients

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Graham.Trope@uhn.on.ca

**Name:** Graham Prof Trope, PhD, FRCSC

**Phone:** 4166035317

**Role:** CONTACT

**Contact 2:**

**Email:** y.buys@utoronta.ca

**Name:** Yvonne Prof Buys, MD, FRCSC

**Phone:** 4166035682

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Toronto

**Contacts:**

***Contact 1:***

- **Email:** raham.Trope@uhn.on.ca

- **Name:** Graham Prof Trope, PhD, FRCSC

- **Phone:** 4166035317

- **Role:** CONTACT

***Contact 2:***

- **Name:** Graham E Trope, PhD, FRCSC

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Yvonne M Buys, MD, FRCSC

- **Role:** SUB_INVESTIGATOR

***Contact 4:***

- **Name:** Hussain Patel, MD

- **Role:** SUB_INVESTIGATOR

***Contact 5:***

- **Name:** John Flanagan, DO, PhD

- **Role:** SUB_INVESTIGATOR

***Contact 6:***

- **Name:** Colin Shapiro, MD, PhD

- **Role:** SUB_INVESTIGATOR

***Contact 7:***

- **Name:** Farzana Jahan, MD

- **Role:** SUB_INVESTIGATOR

**Country:** Canada

**Facility:** Toronto Western Hospital

**State:** Ontario

**Status:** RECRUITING

**Zip:** M5T 2S8

### References Module

#### References

**Citation:** Beltran-Agullo L, Buys YM, Jahan F, Shapiro CM, Flanagan JG, Cheng J, Trope GE. Twenty-four hour intraocular pressure monitoring with the SENSIMED Triggerfish contact lens: effect of body posture during sleep. Br J Ophthalmol. 2017 Oct;101(10):1323-1328. doi: 10.1136/bjophthalmol-2016-308710. Epub 2017 Mar 7.

**PMID:** 28270491

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009798

- Term: Ocular Hypertension

- ID: D000005128

- Term: Eye Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

### Condition Browse Module - Browse Leaves

- ID: M9556

- Name: Hemorrhage

- Relevance: LOW

- As Found: Unknown

- ID: M9013

- Name: Glaucoma

- Relevance: HIGH

- As Found: Glaucoma

- ID: M10024

- Name: Hypertension

- Relevance: LOW

- As Found: Unknown

- ID: M12731

- Name: Ocular Hypertension

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005901

- Term: Glaucoma

### Misc Info Module

- Version Holder: 2024-05-24
