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Bandage Contact Lens in Post Operative Ptosis Patients

Primary Purpose

Ptosis, Blepharoptosis

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Bandage contact lens
Sponsored by
St. Joseph's Healthcare Hamilton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ptosis focused on measuring Ptosis, Blepharoptosis, bandage contact lens, fasanella servat procedure

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • St. Joseph's Hospital HamiltonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Bandage contact lens

Sham contact lens (immediate removal)

Arm Description

Placing a bandage contact lens in one eye.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
November 8, 2017
Last Updated
April 19, 2018
Sponsor
St. Joseph's Healthcare Hamilton
Collaborators
Robert Adam, Forough Farrokhyar, Sivisan Suntheralingam
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1. Study Identification

Unique Protocol Identification Number
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 21, 2018 (Actual)
Primary Completion Date
December 1, 2018 (Anticipated)
Study Completion Date
December 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Healthcare Hamilton
Collaborators
Robert Adam, Forough Farrokhyar, Sivisan Suntheralingam

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ptosis, Blepharoptosis
Keywords
Ptosis, Blepharoptosis, bandage contact lens, fasanella servat procedure

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
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.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bandage contact lens
Arm Type
Active Comparator
Arm Description
Placing a bandage contact lens in one eye.
Arm Title
Sham contact lens (immediate removal)
Arm Type
No Intervention
Arm 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.
Intervention Type
Device
Intervention Name(s)
Bandage contact lens
Intervention Description
Bandage contact lens
Primary Outcome Measure Information:
Title
Patient's pain/discomfort
Description
This will be obtained using the Eye Sensations Scale where the patient can select a box from None, Mild, Moderate, Severe, to Extreme.
Time Frame
One week post-operation.
Secondary Outcome Measure Information:
Title
Blurry vision
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).
Time Frame
One week post-operation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John Harvey, M.D.
Phone
905-522 1155
Ext
38095
Email
johntharvey@gmail.com
Facility Information:
Facility Name
St. Joseph's Hospital Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8G 5E4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Harvey, M.D.
Phone
905-522 1155
Ext
38095
Email
johntharvey@gmail.com
First Name & Middle Initial & Last Name & Degree
John Harvey, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared with others.

Learn more about this trial

Bandage Contact Lens in Post Operative Ptosis Patients

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