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Bandage Contact Lens in Post Operative Ptosis Patients

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ClinicalTrials.gov Identifier: NCT03375879
Recruitment Status : Not yet recruiting
First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Ptosis Blepharoptosis Device: Bandage contact lens

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Official Title: The Role of Bandage Contact Lens in Post-operative Patients Undergoing Fasanella Servat Ptosis Repair
Anticipated Study Start Date : January 10, 2018
Estimated Primary Completion Date : May 1, 2018
Estimated Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Bandage contact lens
Placing a bandage contact lens in one eye.
Device: Bandage contact lens
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.


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03375879


Contacts
Contact: John Harvey, M.D. 905-522 1155 ext 38095 johntharvey@gmail.com

Locations
Canada, Ontario
St. Joseph's Hospital Hamilton Enrolling by invitation
Hamilton, Ontario, Canada, L8G 5E4
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
Robert Adam
Forough Farrokhyar
Sivisan Suntheralingam
  Study Documents (Full-Text)

Documents provided by John Harvey, St. Joseph's Healthcare Hamilton:
More Information

Responsible Party: John Harvey, Director of Oculoplastic, Reconstructive, Lacrimal and Orbital Service, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT03375879     History of Changes
Other Study ID Numbers: StJosephharveyj
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared with others.

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

Keywords provided by John Harvey, St. Joseph's Healthcare Hamilton:
Ptosis
Blepharoptosis
bandage contact lens
fasanella servat procedure

Additional relevant MeSH terms:
Prolapse
Blepharoptosis
Pathological Conditions, Anatomical
Eyelid Diseases
Eye Diseases