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Bandage Contact Lens in Post Operative Ptosis Patients

S

St. Joseph's Healthcare Hamilton

Status

Unknown

Conditions

Blepharoptosis
Ptosis

Treatments

Device: Bandage contact lens

Study type

Interventional

Funder types

Other

Identifiers

NCT03375879
StJosephharveyj

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

Bandage contact lens
Active Comparator group
Description:
Placing a bandage contact lens in one eye.
Treatment:
Device: Bandage contact lens
Sham contact lens (immediate removal)
No Intervention group
Description:
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.

Trial documents
1

Trial contacts and locations

1

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Central trial contact

John Harvey, M.D.

Data sourced from clinicaltrials.gov

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