Bandage Contact Lens in Post Operative Ptosis Patients

Not Applicable

• Conditions: Ptosis; Blepharoptosis
• Interventions: Device: Bandage contact lens

• Registration Number: NCT03375879
• Lead Sponsor: St. Joseph's Healthcare Hamilton

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 Timeline

• Study First Submitted: 2017-11-08
• Study First Submitted QC: 2017-12-14
• Study First Posted: 2017-12-18
• Study Start: 2018-02-21
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-19
• Last Update Posted: 2018-04-23
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bandage contact lens	Bandage contact lens	Placing a bandage contact lens in one eye.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).

Trial Locations

Locations (1)

St. Joseph's Hospital Hamilton; 🇨🇦 Hamilton, Ontario, Canada