Recruiting

Bandage Contact Lens

Sponsor:

St. Joseph's Healthcare Hamilton

Code:

NCT03375879

Conditions

Ptosis

Blepharoptosis

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Interventions

Bandage contact lens

Study Details

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.

Conditions

Ptosis

Blepharoptosis

Study ID

NCT03375879

Start date

Feb 21, 2018

Status verified date

Apr, 2018

Completion date

Dec 1, 2018

Anticipated

Primary completion date

Dec 1, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Bandage contact lens

Placing a bandage contact lens in one eye.

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.

Interventions

Bandage contact lens

Bandage contact lens

Primary outcome measure

  • Patient's pain/discomfort [ Time Frame: One week post-operation. ]

Central Contacts and Locations

Central contacts

Locations

St. Joseph's Hospital Hamilton

Recruiting

Hamilton, Ontario, Canada, L8G 5E4

Contacts

Principal Investigator:

John Harvey, M.D.

More Information

Sponsor

St. Joseph's Healthcare Hamilton

Last update posted

Apr 23, 2018

Last verified

Apr, 2018

Keywords

  • Ptosis
  • Blepharoptosis
  • bandage contact lens
  • fasanella servat procedure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Joseph's Healthcare Hamilton on 2018-04-23.