## Protocol Section
### Identification Module
**NCT ID:** NCT03375879

**Brief Title:** Bandage Contact Lens in Post Operative Ptosis Patients

**Official Title:** The Role of Bandage Contact Lens in Post-operative Patients Undergoing Fasanella Servat Ptosis Repair

#### Organization Study ID Info
**ID:** StJosephharveyj
#### Organization
**Class:** OTHER
**Full Name:** St. Joseph's Healthcare Hamilton
### Status Module
#### Completion Date
**Date:** 2018-12-01

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2018-04-23

**Type:** ACTUAL

**Last Update Submit Date:** 2018-04-19

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2018-12-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2018-02-21

**Type:** ACTUAL

**Status Verified Date:** 2018-04

#### Study First Post Date
**Date:** 2017-12-18
**Type:** ACTUAL
**Study First Submit Date:** 2017-11-08
**Study First Submit QC Date:** 2017-12-14
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Robert Adam

**Class:** UNKNOWN

**Name:** Forough Farrokhyar

**Class:** UNKNOWN

**Name:** Sivisan Suntheralingam

#### Lead Sponsor

**Class:** OTHER

**Name:** St. Joseph's Healthcare Hamilton

#### Responsible Party

**Investigator Affiliation:** St. Joseph's Healthcare Hamilton

**Investigator Full Name:** John Harvey

**Investigator Title:** Director of Oculoplastic, Reconstructive, Lacrimal and Orbital Service

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** True

### Description Module

**Brief Summary:** This study is being conducted to determine whether the use of bandage contact lens after ptosis surgery provides any benefits for the patient or is unnecessary.

**Detailed Description:** This study is being conducted to determine whether the use of bandage contact lens after ptosis surgery provides any benefits for the patient or is unnecessary. The investigators hope to show through questionnaires based on the patient's experience after their surgery to see if the bandage contact lens has provided any benefit for the patient. This is a randomized control trial in which patients undergoing bilateral ptosis surgery (Fasanella servat procedure) will have one of their eyes randomized to receive a bandage contact lens after surgery while the other eye will not receive anything.In this randomized control trial, patients requiring surgery with bilateral ptosis will have one eye randomized to receive a bandage contact lens whereas the other eye will not after their surgery. Follow up will occur in one week where the outcomes will be obtained through questionnaires.

### Conditions Module

**Conditions:**

- Ptosis

- Blepharoptosis

**Keywords:**

- Ptosis

- Blepharoptosis

- bandage contact lens

- fasanella servat procedure

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** The investigators will place a contact lens on both eyes and immediately take it off from one (this will be the sham lens eye). Randomization of the lens placement will be determined by a flip of a coin (heads - keep lens on right eye. Tails - keep lens on left eye). Investigator will randomly generate for each patient whether the contact lens will be kept on right or left eye, sham contact lens will be placed on other eye, placing it and immediately removing it. Therefore, the patient will not know which eye has a lens.

##### Masking Info

**Masking:** SINGLE

**Masking Description:** The investigator will place a contact lens on both eyes and immediately take it off from one (this will be the sham lens eye). Randomization of the lens placement will be determined by a flip of a coin (heads - keep lens on right eye. Tails - keep lens on left eye). Investigator will randomly generate for each patient whether the contact lens will be kept on right or left eye, sham contact lens will be placed on other eye, placing it and immediately removing it. Therefore, the patient will not know which eye has a lens.

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Placing a bandage contact lens in one eye.

**Intervention Names:**

- Device: Bandage contact lens

**Label:** Bandage contact lens

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Sham contact lens will be placed on other eye, placing it and immediately removing it so patient does not know which eye will have a bandage contact lens.

**Label:** Sham contact lens (immediate removal)

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Bandage contact lens

**Description:** Bandage contact lens

**Name:** Bandage contact lens

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** This will be obtained using the Eye Sensations Scale where the patient can select a box from None, Mild, Moderate, Severe, to Extreme.

**Measure:** Patient's pain/discomfort

**Time Frame:** One week post-operation.

#### Secondary Outcomes

**Description:** This will be measured using one question from the Ocular Surface Disease Index (OSDI), with a scale from 0 (none of the time) to 4 (all of the time).

**Measure:** Blurry vision

**Time Frame:** One week post-operation.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* patients who have bilateral ptosis (drooping eyelids) and will require surgery to correct this

Exclusion Criteria:

* patient having any other eye related pathologies

**Healthy Volunteers:** True

**Minimum Age:** 50 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** johntharvey@gmail.com

**Name:** John Harvey, M.D.

**Phone:** 905-522 1155

**Phone Ext:** 38095

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Hamilton

**Contacts:**

***Contact 1:***

- **Email:** johntharvey@gmail.com

- **Name:** John Harvey, M.D.

- **Phone:** 905-522 1155

- **Phone Ext:** 38095

- **Role:** CONTACT

***Contact 2:***

- **Name:** John Harvey, M.D.

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Canada

**Facility:** St. Joseph's Hospital Hamilton

**State:** Ontario

**Status:** RECRUITING

**Zip:** L8G 5E4

### IPD Sharing Statement Module

**Description:** IPD will not be shared with others.

**IPD Sharing:** NO

## Document Section

### Large Document Module

#### Large Docs

- Date: 2017-10-17

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 498576

- Type Abbrev: Prot_SAP

- Upload Date: 2017-11-23T21:41

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020763

- Term: Pathological Conditions, Anatomical

- ID: D000005141

- Term: Eyelid Diseases

- 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

### Condition Browse Module - Browse Leaves

- ID: M14261

- Name: Prolapse

- Relevance: HIGH

- As Found: Ptosis

- ID: M5044

- Name: Blepharoptosis

- Relevance: HIGH

- As Found: Blepharoptosis

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

- ID: M8284

- Name: Eyelid Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001763

- Term: Blepharoptosis

- ID: D000011391

- Term: Prolapse

### Misc Info Module

- Version Holder: 2024-05-24
