BlepharoptosisNCT01968174
Astigmatic Changes Secondary to Eyelid Surgeries
An observational study of Blepharoptosis, run by Meir Medical Center at 3 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Blepharoptosis
- How many people
- 30 participants
- Where
- 3 sitesIsrael
- Study dates
- Jun 2014to Jun 2015
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients undergoing eyelid surgery.
Who may be able to join
- upper lid blepharochalasis
Who cannot join
- prior eyelid trauma mental retardation or other causes preventing from signing an agreement form
Trial locations and contacts
3 sites in 1 country.
Israel3 sites, 2 recruiting
- Recruiting
Meir Medical center
Kfar Saba, Israel
arik nemet, Dr., +972-9747-2154, nemet.arik@gmail.com
ARIK NEMET, Dr
- Suspended
Meir Medical Center
Kfar Saba, Israel
- Recruiting
Meir Medical Center
Kfar Saba
ARIK NEMET, DR, +972-9747-2154, arik.nemet@gmail.com
SHAY OFIR, DR, +972-9747-2154, shayofir1@gmail.com
About this study
Official title: Astigmatic Corneal Changes Secondary to Eyelid Surgery
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.
Read the detailed description
Patients registered for a lid surgery due to blepharoptosis or ptosis will undergo a topographic examination prior to and 3 months post operative in addition to their regular pre and post operative examination astigmatic shift will be mathematically measured.
- Conditions
- Blepharoptosis
- Keywords
- astigmatism, lid surgery, older than 40 years, can sign an acceptance form, uper lid surgery
- Medical subject headings
- Blepharoptosis, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| eyelid displacement | patients suffering from eyelid disposition due to ptosis, blepharochalasis and are registered for eyelid surgeries will be assigned for the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
astigmatic corneal decrease following eyelid surgery
eyelid change in position will change the effect on corneal astigmatism measured 3 months post surgery
Measured: 3 months
Secondary outcomes (1)
type of astigmatism
a change from against the rule astigmatism to with the rule astigmatism following eyelid surgery will be evaluated
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2013 (estimated)
- Study startJun 2014
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlepharoptosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, shay ofir, Meir Medical Center
- Investigators
- Arye - Nemet, MD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968174
- Sponsor's protocol ID
- oculoplasticmeir001
- Status last verified
- Aug 2014
- First submitted
- 19 Oct 2013
- Last updated
- 12 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Astigmatic Corneal Changes Secondary to Eyelid Surgery
- ClinicalTrials.gov ID
- NCT01968174
- Acronym / sponsor ID
- oculoplasticmeir001
- Conditions
- Blepharoptosis
- Keywords
- astigmatism, lid surgery, older than 40 years, can sign an acceptance form, uper lid surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 23 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients registered for a lid surgery due to blepharoptosis or ptosis will undergo a topographic examination prior to and 3 months post operative in addition to their regular pre and post operative examination astigmatic shift will be mathematically measured.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eyelid displacement | – | –patients suffering from eyelid disposition due to ptosis, blepharochalasis and are registered for eyelid surgeries will be assigned for the study |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing eyelid surgery.
Key inclusion criteria (1 listed)
- upper lid blepharochalasis
Key exclusion criteria (1 listed)
- prior eyelid trauma mental retardation or other causes preventing from signing an agreement form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
astigmatic corneal decrease following eyelid surgery
Time frame: 3 months
eyelid change in position will change the effect on corneal astigmatism measured 3 months post surgery
1 secondary outcome
type of astigmatism
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arye - Nemet, MD principal investigator
Meir Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blepharoptosis, run by Meir Medical Center at 3 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ARIK NEMET, DR (+972-9747-2154, arik.nemet@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
astigmatic corneal decrease following eyelid surgery (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2014.