Bandage Contact Lens in Post Operative Ptosis Patients

Blepharoptosis Clinical Trial

Official title:

The Role of Bandage Contact Lens in Post-operative Patients Undergoing Fasanella Servat Ptosis Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03375879
• Other study ID #: StJosephharveyj
• Status: Recruiting
• Phase: N/A
• First received: November 8, 2017
• Last updated: April 19, 2018
• Start date: February 21, 2018
• Est. completion date: December 1, 2018

Study information

• Verified date: April 2018
• Source: St. Joseph's Healthcare Hamilton
• Contact: John Harvey, M.D.
• Phone: 905-522 1155
• Email: johntharvey[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blepharoptosis
• Prolapse
• Ptosis

Intervention

Device:
• Bandage contact lens
Bandage contact lens

Locations

Country	Name	City	State
Canada	St. Joseph's Hospital Hamilton	Hamilton	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton	Forough Farrokhyar, Robert Adam, Sivisan Suntheralingam

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Blurry vision	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).	One week post-operation.