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Bandage Contact Lens in Post Operative Ptosis Patients

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ClinicalTrials.gov Identifier: NCT03375879
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : April 23, 2018
Sponsor:
Collaborators:
Robert Adam
Forough Farrokhyar
Sivisan Suntheralingam
Information provided by (Responsible Party):
John Harvey, St. Joseph's Healthcare Hamilton

Tracking Information
First Submitted Date  ICMJE November 8, 2017
First Posted Date  ICMJE December 18, 2017
Last Update Posted Date April 23, 2018
Actual Study Start Date  ICMJE February 21, 2018
Estimated Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2017)
Patient's pain/discomfort [ Time Frame: One week post-operation. ]
This will be obtained using the Eye Sensations Scale where the patient can select a box from None, Mild, Moderate, Severe, to Extreme.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03375879 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2017)
Blurry vision [ Time Frame: One week post-operation. ]
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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bandage Contact Lens in Post Operative Ptosis Patients
Official Title  ICMJE The Role of Bandage Contact Lens in Post-operative Patients Undergoing Fasanella Servat Ptosis Repair
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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: Single (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.
Primary Purpose: Supportive Care
Condition  ICMJE
  • Ptosis
  • Blepharoptosis
Intervention  ICMJE Device: Bandage contact lens
Bandage contact lens
Study Arms  ICMJE
  • Active Comparator: Bandage contact lens
    Placing a bandage contact lens in one eye.
    Intervention: Device: Bandage contact lens
  • No Intervention: Sham contact lens (immediate removal)
    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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 14, 2017)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2018
Estimated Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: John Harvey, M.D. 905-522 1155 ext 38095 johntharvey@gmail.com
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03375879
Other Study ID Numbers  ICMJE StJosephharveyj
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: IPD will not be shared with others.
Responsible Party John Harvey, St. Joseph's Healthcare Hamilton
Study Sponsor  ICMJE St. Joseph's Healthcare Hamilton
Collaborators  ICMJE
  • Robert Adam
  • Forough Farrokhyar
  • Sivisan Suntheralingam
Investigators  ICMJE Not Provided
PRS Account St. Joseph's Healthcare Hamilton
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP