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Bandage Contact Lens in Post Operative Ptosis Patients

NCT ID: NCT03375879

Last Updated: 2018-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-21

Study Completion Date

2018-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ptosis Blepharoptosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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Bandage contact lens

Placing a bandage contact lens in one eye.

Group Type ACTIVE_COMPARATOR

Bandage contact lens

Intervention Type DEVICE

Bandage contact lens

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bandage contact lens

Bandage contact lens

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Robert Adam

UNKNOWN

Sponsor Role collaborator

Forough Farrokhyar

UNKNOWN

Sponsor Role collaborator

Sivisan Suntheralingam

UNKNOWN

Sponsor Role collaborator

St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role lead

Responsible Party

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John Harvey

Director of Oculoplastic, Reconstructive, Lacrimal and Orbital Service

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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St. Joseph's Hospital Hamilton

Hamilton, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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John Harvey, M.D.

Role: CONTACT

[email protected]
905-522 1155 ext. 38095

Facility Contacts

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John Harvey, M.D.

Role: primary

[email protected]
905-522 1155 ext. 38095

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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StJosephharveyj

Identifier Type: -

Identifier Source: org_study_id

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