Bandage Contact Lens in Post Operative Ptosis Patients

NCT03375879 | Unknown FDA Device

• 1 other identifier: StJosephharveyj
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Ptosis; Blepharoptosis; bandage contact lens; fasanella servat procedure

Outcome Measures

Primary Outcomes (1)

• 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.

  One week post-operation.

Secondary Outcomes (1)

• Blurry vision

  One week post-operation.

Study Arms (2)

Bandage contact lens

ACTIVE COMPARATOR

Placing a bandage contact lens in one eye.

Device: Bandage contact lens

Sham contact lens (immediate removal)

NO INTERVENTION

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 DEVICE

Bandage contact lens

Bandage contact lens

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who have bilateral ptosis (drooping eyelids) and will require surgery to correct this

You may not qualify if:

• patient having any other eye related pathologies

Sponsors & Collaborators

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

Study Sites (1)

St. Joseph's Hospital Hamilton

Hamilton, Ontario, L8G 5E4, Canada

RECRUITING

MeSH Terms

Conditions

Blepharoptosis

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Central Study Contacts

John Harvey, M.D.

CONTACT

905-522 1155; johntharvey@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Oculoplastic, Reconstructive, Lacrimal and Orbital Service

Model Details: 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.

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: December 18, 2017
• Study Start: February 21, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 23, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)