An interventional study of Bandage contact lens in Ptosis and Blepharoptosis, sponsored by St. Joseph's Healthcare Hamilton. Status unknown at 1 site in Canada. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-23.
Sponsored by St. Joseph's Healthcare Hamilton · Not applicable, Interventional, and Supportive care
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.
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.
63 studies on the registry are indexed under Blepharoptosis; 16 are open to participants now.
This study's planned enrollment of 30 is below the median of 45 across 50 interventional studies indexed under Blepharoptosis.
Browse Blepharoptosis studies →St. Joseph's Healthcare Hamilton is the lead sponsor of 143 studies on the registry; 33 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Placing a bandage contact lens in one eye.
Device: Bandage contact lens
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.
Bandage contact lens
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.
Time frame: One week post-operation.
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).
Time frame: One week post-operation.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — IPD will not be shared with others.
Started Feb 2018 (actual). Primary completion is estimated for Dec 2018, 9 months after the start.
Of 22 interventional studies with no phase under Blepharoptosis, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 62. This study's planned 9 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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