NCT01968174

Brief Summary

Eyelid surgeries change the lid position over the cornea. Previous surgeries evaluated astigmatic corneal changes in children undergoing ptosis repair. Only several studies evaluated astigmatic changes following eyelid surgeries in elderly patients. The investigators aim is to estimate this change, implications on corneal astigmatism may have great effect to future cataract surgeries for this group of patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2014

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 23, 2013

Completed
7 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

August 12, 2014

Status Verified

August 1, 2014

Enrollment Period

1 year

First QC Date

October 19, 2013

Last Update Submit

August 11, 2014

Conditions

Blepharoptosis

Keywords

astigmatismlid surgeryolder than 40 yearscan sign an acceptance formuper lid surgery

Outcome Measures

Primary Outcomes (1)

  • astigmatic corneal decrease following eyelid surgery

    eyelid change in position will change the effect on corneal astigmatism measured 3 months post surgery

    3 months

Secondary Outcomes (1)

  • type of astigmatism

    3 months

Other Outcomes (1)

  • complications

    3 months

Study Arms (1)

eyelid displacement

patients suffering from eyelid disposition due to ptosis, blepharochalasis and are registered for eyelid surgeries will be assigned for the study

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients undergoing eyelid surgery.

You may qualify if:

  • upper lid blepharochalasis

You may not qualify if:

  • prior eyelid trauma mental retardation or other causes preventing from signing an agreement form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Meir Medical center

Kfar Saba, Israel, Israel

RECRUITING

Meir Medical Center

Kfar Saba, Israel, Israel

SUSPENDED

Meir Medical Center

Kfar Saba, Israel

RECRUITING

MeSH Terms

Conditions

BlepharoptosisAstigmatism

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye DiseasesRefractive Errors

Study Officials

  • Arye - Nemet, MD

    Meir Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ARIK NEMET, DR

CONTACT

+972-9747-2154arik.nemet@gmail.com

SHAY OFIR, DR

CONTACT

+972-9747-2154shayofir1@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
SHAY OFIR

Study Record Dates

First Submitted

October 19, 2013

First Posted

October 23, 2013

Study Start

June 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

August 12, 2014

Record last verified: 2014-08

Locations

IL(3)