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Bandage Contact Lens in Post Operative Ptosis Patients

Sponsor
St. Joseph's Healthcare Hamilton (Other)
Overall Status
Unknown status
CT.gov ID
NCT03375879
Collaborator
Robert Adam (Other), Forough Farrokhyar (Other), Sivisan Suntheralingam (Other)
30
Enrollment
1
Location
2
Arms
9.3
Anticipated Duration (Months)
3.2
Patients Per Site Per Month

Study Details

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 Phase
  • Device: Bandage contact lens
 N/A

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
Anticipated 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.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
Actual Study Start Date :
Feb 21, 2018
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Dec 1, 2018

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 [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 [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

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 St. Joseph's Hospital Hamilton Hamilton Ontario Canada L8G 5E4

Sponsors and Collaborators

  • St. Joseph's Healthcare Hamilton
  • Robert Adam
  • Forough Farrokhyar
  • Sivisan Suntheralingam

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
John Harvey, Director of Oculoplastic, Reconstructive, Lacrimal and Orbital Service, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier:
NCT03375879
Other Study ID Numbers:
  • StJosephharveyj
First Posted:
Dec 18, 2017
Last Update Posted:
Apr 23, 2018
Last Verified:
Apr 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by John Harvey, Director of Oculoplastic, Reconstructive, Lacrimal and Orbital Service, St. Joseph's Healthcare Hamilton
Ptosis
Blepharoptosis
bandage contact lens
fasanella servat procedure
Additional relevant MeSH terms:
Blepharoptosis
Prolapse

Study Results

No Results Posted as of Apr 23, 2018