Bandage Contact Lens in Post Operative Ptosis Patients | NCT03375879

Studies
Bandage Contact Lens in Post Operative Ptosis Patients

NCT03375879

Sponsor

St. Joseph's Healthcare Hamilton

Status

Unknown status

Last Update Posted

Apr 23, 2018Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Ptosis
Blepharoptosis

Interventions

Bandage contact lens

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 21, 2018Actual

Primary Completion Date

Dec 1, 2018Estimated

Completion Date

Dec 1, 2018Estimated

First Submitted Date

Nov 8, 2017

First Submission Date that Met QC Criteria

Dec 14, 2017

First Posted Date

Dec 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2018

Last Update Posted Date

Apr 23, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

John Harvey, Director of Oculoplastic, Reconstructive, Lacrimal and Orbital Service, St. Joseph's Healthcare HamiltonPrincipal Investigator

Lead Sponsor

St. Joseph's Healthcare HamiltonOTHER

Collaborators

Name	Class
Robert Adam	UNKNOWN
Forough Farrokhyar	UNKNOWN
Sivisan Suntheralingam	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bandage contact lens	Active Comparator	Placing a bandage contact lens in one eye.	Device: Bandage contact lens
Sham contact lens (immediate removal)	No Intervention	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.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bandage contact lens	Device	Bandage contact lens	Bandage contact lens

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient's pain/discomfort	This will be obtained using the Eye Sensations Scale where the patient can select a box from None, Mild, Moderate, Severe, to Extreme.	One week post-operation.

Secondary Outcomes

Measure	Description	Time Frame
Blurry vision	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).	One week post-operation.

Other Outcomes

Not provided

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
John Harvey, M.D.	Contact	905-522 1155	38095	johntharvey@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Joseph's Hospital Hamilton	Recruiting	Hamilton	Ontario	L8G 5E4	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

IPD will not be shared with others.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Oct 17, 2017	Nov 23, 2017	Prot_SAP_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D001763	Blepharoptosis

Ancestor Terms

ID	Term
D005141	Eyelid Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

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