Dry Eye SyndromeNCT02376556
The Effect of Eyelid Surgery on Dry Eye - a Prospective Study
An observational study of Dry Eye Syndrome and Ptosis, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The investigators aim to assess the effect of blepharoplasty with or without muller muscle resection on the symptoms of dry eye syndrome. this will be an observational study in which patients undergoing the aforementioned surgeries will be followed up and monitored for dry eye symptoms. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Dry Eye Syndrome, Ptosis, Dermatochalasis
- How many people
- 54 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2015to Mar 2018
- 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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are referred for blepharoplasty with or without muller muscle resection in the oculoplastic clinic in our institution
Who may be able to join
- patients who are referred for blepharoplasty with or without muller muscle resection in the oculoplastic clinic in our institution
- no other ophthalmic procedures planned for the patient in study period
- ability to undergo full ophthalmic examination as stated in the study protocol
- Ability to complete the dry eye questionnaire
- ability to sign an informed consent form
Who cannot join
- previous eyelid surgery
- other orbital or lacrimal gland disease
- concurrent use of contact lenses
- concurrent use of Restasis
- previous glaucoma surgery
- use of punctual plugs
- pregnant or nursing women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prevalence of Dry Eye Syndrome Among Patients Who Underwent Upper Eyelids Blepharoplasty With and Without Muller Muscle Resection
The investigators aim to assess the effect of blepharoplasty with or without muller muscle resection on the symptoms of dry eye syndrome. this will be an observational study in which patients undergoing the aforementioned surgeries will be followed up and monitored for dry eye symptoms.
Read the detailed description
Patients who are referred for blepharoplasty with or without muller muscle resection in the oculoplastic clinic in the investigators institution, will be offered to participate in the study. After filling and informed consent form, patients recruited will fill in a questionnaire about dry eye symptoms, and will be examined by an ophthalmologist for visual acuity, intra ocular pressure, anterior segment examination using a slit lamp biomicroscopy, schirmer test, tear break up time assessment and tear osmolarity. These are all standard examination in ophthalmology. The surgical procedure planned to correct the eyelid pathology will not be affected by the results of these examinations.
The same combination of ophthalmic examination will by done on postoperative follow-up examination 1 week, 1 month and 3 months after the surgery. Dry eye questionnaire will be filled in by the patients on postoperative follow-up examination 1 month and 3 months after the surgery.
This data will help us assess the effect of these common surgical procedures on dry eye symptoms.
- Conditions
- Dry Eye Syndrome, Ptosis, Dermatochalasis
- Keywords
- Dry eye syndrome, Blepharoplasty, Muller muscle resection surgery
- Medical subject headings
- Dry Eye Syndromes, Blepharoptosis, Cutis Laxa
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 |
|---|---|---|
| Blepharoplasty | patients undergoing upper eyelid blepharoplasty | |
| blepharoplasty and muller muscle resection | patients undergoing a combined blepharoplasty and muller muscle resection surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective assessment of dry eye syndrome
Measured: 3 months postoperatively
Secondary outcomes (1)
Subjective assessment of dry eye syndrome
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromeStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Guy Ben Simon, Sheba Medical Center
- Investigators
- Guy J Ben Simon, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376556
- Sponsor's protocol ID
- SHEBA-14-1496-GBS-CTIL
- Status last verified
- Oct 2019
- First submitted
- 25 Feb 2015
- Last updated
- 15 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Dry Eye Syndrome Among Patients Who Underwent Upper Eyelids Blepharoplasty With and Without Muller Muscle Resection
- ClinicalTrials.gov ID
- NCT02376556
- Acronym / sponsor ID
- SHEBA-14-1496-GBS-CTIL
- Conditions
- Dry Eye Syndrome, Ptosis, Dermatochalasis
- Keywords
- Dry eye syndrome, Blepharoplasty, Muller muscle resection surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Mar 2015 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 3 Mar 2015 (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.
The investigators aim to assess the effect of blepharoplasty with or without muller muscle resection on the symptoms of dry eye syndrome. this will be an observational study in which patients undergoing the aforementioned surgeries will be followed up and monitored for dry eye symptoms.
Detailed description
Patients who are referred for blepharoplasty with or without muller muscle resection in the oculoplastic clinic in the investigators institution, will be offered to participate in the study. After filling and informed consent form, patients recruited will fill in a questionnaire about dry eye symptoms, and will be examined by an ophthalmologist for visual acuity, intra ocular pressure, anterior segment examination using a slit lamp biomicroscopy, schirmer test, tear break up time assessment and tear osmolarity. These are all standard examination in ophthalmology. The surgical procedure planned to correct the eyelid pathology will not be affected by the results of these examinations.
The same combination of ophthalmic examination will by done on postoperative follow-up examination 1 week, 1 month and 3 months after the surgery. Dry eye questionnaire will be filled in by the patients on postoperative follow-up examination 1 month and 3 months after the surgery.
This data will help us assess the effect of these common surgical procedures on dry eye symptoms.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blepharoplasty | – | –patients undergoing upper eyelid blepharoplasty |
| blepharoplasty and muller muscle resection | – | –patients undergoing a combined blepharoplasty and muller muscle resection surgery |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are referred for blepharoplasty with or without muller muscle resection in the oculoplastic clinic in our institution
Key inclusion criteria (5 listed)
- patients who are referred for blepharoplasty with or without muller muscle resection in the oculoplastic clinic in our institution
- no other ophthalmic procedures planned for the patient in study period
- ability to undergo full ophthalmic examination as stated in the study protocol
- Ability to complete the dry eye questionnaire
- ability to sign an informed consent form
Key exclusion criteria (7 listed)
- previous eyelid surgery
- other orbital or lacrimal gland disease
- concurrent use of contact lenses
- concurrent use of Restasis
- previous glaucoma surgery
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
Objective assessment of dry eye syndrome
Time frame: 3 months postoperatively
1 secondary outcome
Subjective assessment of dry eye syndrome
Time frame: 3 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
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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.
Guy J Ben Simon, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye Syndrome and Ptosis, run by Sheba Medical Center at 1 site 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective assessment of dry eye syndrome (time frame: 3 months postoperatively). 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 15 Oct 2019.