BlepharoptosisNCT02501187
Risk of Dry Eye Post Different Surgeries for Blepharoptosis Repair
A study testing Levator advancement, Müller's muscle-conjunctival resection procedure and White line advancement in people with Blepharoptosis, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Blepharoptosis, inferodisplacement of the upper eyelid, can be congenital or acquired. Acquired Blepharoptosis is usually aponeurotic, due to stretching or disinsertion of the levator aponeurosis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blepharoptosis
- What is being tested?
- Levator advancement, Müller's muscle-conjunctival resection procedure and White line advancement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteIsrael
- Study dates
- 8 Oct 2015to Jul 2020
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ptosis which indicate surgical repair
- The ptosis must be suitable for repair in any of the procedures
Who cannot join
- Systemic disease which may cause ocular surface disease (eg Sjogren disease)
- Previous orbital or eyelid surgery
- Significantly dry eyes
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Ophthalmology clinics, Rabin Medical Center
Petah Tikva
Maya Eiger, MD, +972-3-9376017, mayae2@clalit.org.il
Maya Eiger, MD
About this study
Official title: Comparison Between Three Different Surgeries for Blepharoptosis Repair and Their Impact on Dry Eye Status
Blepharoptosis, inferodisplacement of the upper eyelid, can be congenital or acquired. Acquired Blepharoptosis is usually aponeurotic, due to stretching or disinsertion of the levator aponeurosis. Treatment is surgical and can be performed by three common procedures - Levator advancement, Müller's muscle-conjunctival resection procedure and White line advancement. A number of reports inspected the possibility that Blepharoptosis repair procedures may cause deterioration in dry eye status. The investigators would like to assess whether there is a difference between the different procedures in their influence on dry eye status.
- Conditions
- Blepharoptosis
- Being tested
- Levator advancement, Müller's muscle-conjunctival resection procedure, White line advancement
- Medical subject headings
- Blepharoptosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levator advancementProcedure or surgery
A transcutaneous procedure in which the Levator palpebrae aponeurosis is advanced and attached to the tarsus.
Müller's muscle-conjunctival resection procedureProcedure or surgery
A transconjunctival procedure in which part of the muller muscle and conjunctiva are resected.
White line advancementProcedure or surgery
A transconjunctival procedure in which the Levator palpebrae aponeurosis is advanced and attached to the tarsus.
| Study group | Role | What they receive |
|---|---|---|
| Patients operated for ptosis by levator advancement | Experimental | patients undergoing surgical repair for aponeurotic ptosis by the procedure- levator advancement. Receives: Procedure: Levator advancement |
| Patients operated for ptosis by white line advancement | Experimental | patients undergoing surgical repair for aponeurotic ptosis by the procedure- white line advancement Receives: Procedure: White line advancement |
| Patients operated for ptosis by Müller resection | Experimental | patients undergoing surgical repair for aponeurotic ptosis by the procedure- Müller's muscle-conjunctival resection. Receives: Procedure: Müller's muscle-conjunctival resection procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of objective or subjective deterioration in dry eye status
Dry eye status will be measured by a composite of tests, including Ocular surface disease index (OSDI) questionnaire (which indicates subjective status), and a number of objective tests - Shirmer test, Flurocein dye, Lissamine green dye and tear breakup time
Measured: 6 months
Secondary outcomes (1)
Ptosis repair procedure success
Success will be assessed by comparison of margin reflex distance1 (MRD1) measurement before and after surgery
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study start8 Oct 2015
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maya Eiger, Rabin Medical Center
- Investigators
- Maya Eiger, MD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501187
- Sponsor's protocol ID
- Ptosis-01
- Status last verified
- Apr 2018
- First submitted
- 12 Jul 2015
- Last updated
- 13 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Three Different Surgeries for Blepharoptosis Repair and Their Impact on Dry Eye Status
- ClinicalTrials.gov ID
- NCT02501187
- Acronym / sponsor ID
- Ptosis-01
- Conditions
- Blepharoptosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 8 Oct 2015 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 17 Jul 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.
Blepharoptosis, inferodisplacement of the upper eyelid, can be congenital or acquired. Acquired Blepharoptosis is usually aponeurotic, due to stretching or disinsertion of the levator aponeurosis. Treatment is surgical and can be performed by three common procedures - Levator advancement, Müller's muscle-conjunctival resection procedure and White line advancement. A number of reports inspected the possibility that Blepharoptosis repair procedures may cause deterioration in dry eye status. The investigators would like to assess whether there is a difference between the different procedures in their influence on dry eye status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients operated for ptosis by levator advancement | Experimental | Procedure: Levator advancementpatients undergoing surgical repair for aponeurotic ptosis by the procedure- levator advancement. |
| Patients operated for ptosis by white line advancement | Experimental | Procedure: White line advancementpatients undergoing surgical repair for aponeurotic ptosis by the procedure- white line advancement |
| Patients operated for ptosis by Müller resection | Experimental | Procedure: Müller's muscle-conjunctival resection procedurepatients undergoing surgical repair for aponeurotic ptosis by the procedure- Müller's muscle-conjunctival resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ptosis which indicate surgical repair
- The ptosis must be suitable for repair in any of the procedures
Key exclusion criteria (3 listed)
- Systemic disease which may cause ocular surface disease (eg Sjogren disease)
- Previous orbital or eyelid surgery
- Significantly dry eyes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levator advancementA transcutaneous procedure in which the Levator palpebrae aponeurosis is advanced and attached to the tarsus. | Procedure or surgery | Patients operated for ptosis by levator advancement |
| Müller's muscle-conjunctival resection procedureA transconjunctival procedure in which part of the muller muscle and conjunctiva are resected. | Procedure or surgery | Patients operated for ptosis by Müller resection |
| White line advancementA transconjunctival procedure in which the Levator palpebrae aponeurosis is advanced and attached to the tarsus. | Procedure or surgery | Patients operated for ptosis by white line advancement |
Primary outcome
Diagnosis of objective or subjective deterioration in dry eye status
Time frame: 6 months
Dry eye status will be measured by a composite of tests, including Ocular surface disease index (OSDI) questionnaire (which indicates subjective status), and a number of objective tests - Shirmer test, Flurocein dye, Lissamine green dye and tear breakup time
1 secondary outcome
Ptosis repair procedure success
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2018.
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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.
Maya Eiger, MD principal investigator
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levator advancement, Müller's muscle-conjunctival resection procedure and White line advancement in people with Blepharoptosis, run by Rabin 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 2 inclusion and 3 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 13 Apr 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maya Eiger, MD (+972-3-9376107, mayae2@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of objective or subjective deterioration in dry eye status (time frame: 6 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 13 Apr 2018.