Involutional PtosisNCT03373812
Comparison Between Different Surgical Approaches for the Treatment of INVOLUTIONAL PTOSIS
A study testing Blepharoptosis repair in people with Involutional Ptosis, run by Meir Medical Center.
Trial summary
Involutional ptosis is a known eyelid pathology in which the eyelid margin obscures part of the visual axis (MRD1).Patients usually complains of visual field disturbance, deterioration in quality of life and a poor cosmetic appearance. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Involutional Ptosis
- What is being tested?
- Blepharoptosis repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to Jan 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Involutional ptosis
- No previous eyelid surgery
Who cannot join
- Previous eyelid surgery or trauma
- Congenital ptosis
- Previous glaucoma filtrartion surgery
- Unwillingness for six months followup
Trial locations and contacts
No sites are listed yet.
About this study
Involutional ptosis is a known eyelid pathology in which the eyelid margin obscures part of the visual axis (MRD1).Patients usually complains of visual field disturbance, deterioration in quality of life and a poor cosmetic appearance.
In clinical practice, two main surgical approaches are performed to the repair of involutional ptosis:
- anterior approach - skin incision and levator muscle insertion advancement.
- posterior approach - eyelid reversion and tarsectomy Both approaches has its pro's and con's, but to this date, no solid evidence exists to prove which of these techniques is superior in manner of anatomical and functional results. in this prospective study, patients with involutional ptosis will be randomized to each of surgical approaches groups, parameters concerning surgical and post surgical periods will be evaluated.
Read the detailed description
Involutional ptosis is a known eyelid pathology in which the eyelid margin obscures part of the visual axis (MRD1).Patients usually complains of visual field disturbance, deterioration in quality of life and a poor cosmetic appearance.
In clinical practice, two main surgical approaches are performed to the repair of involutional ptosis:
- anterior approach - skin incision and levator muscle insertion advancement.
- posterior approach - eyelid reversion and tarsectomy Both approaches has its pro's and con's, but to this date, no solid evidence exists to prove which of these techniques is superior in manner of anatomical and functional results. in this prospective study, patients with involutional ptosis will be randomized to each of surgical approaches groups, parameters concerning surgical and post surgical periods will be evaluated.
- Conditions
- Involutional Ptosis
- Being tested
- Blepharoptosis repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blepharoptosis repairProcedure or surgery
levator advancement or mullerectomy
| Study group | Role | What they receive |
|---|---|---|
| anterior approach | Active comparator | patients having involutional ptosis undergoing anterior approach surgical ptosis repair (Levator advancement) Receives: Procedure: Blepharoptosis repair |
| posterior approach | Active comparator | patients having involutional ptosis undergoing posterior approach surgical ptosis repair (mullerectomy) Receives: Procedure: Blepharoptosis repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRD1
Distance in millimeters between corneal light reflex and upper eyelid margin
Measured: 6 months
surgery duration
Time from first incision to last suture (in minutes)
Measured: 3 hours
Levator function
change (in millimeters) in upper eyelid position from downgaze to maximal upgaze
Measured: 6 months
Secondary outcomes (2)
Need for additional eyelid surgery
Any need for oculoplastic additional surgical interventions (Descriptive)
Measured: 6 months
Eyelid or ocular secondary disease
Descriptive
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 posted14 Dec 2017
- Study start1 Jan 2018 (estimated)
- Primary completion1 Jan 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Involutional PtosisStudies 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
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arie Nemet, Meir Medical Center
- Investigators
- Arie Nemet, Prof. (MD), Principal investigator, ophthalmology depertmant, MeirMc, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373812
- Sponsor's protocol ID
- MMC17230-17CTIL
- Status last verified
- Dec 2017
- First submitted
- 4 Dec 2017
- Last updated
- 14 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patel RM, Aakalu VK, Setabutr P, Putterman AM. Efficacy of Muller's Muscle and Conjunctiva Resection With or Without Tarsectomy for the Treatment of Severe Involutional Blepharoptosis. Ophthalmic Plast Reconstr Surg. 2017 Jul/Aug;33(4):273-278. doi: 10.1097/IOP.0000000000000748.
PubMed 27429227Chang S, Lehrman C, Itani K, Rohrich RJ. A systematic review of comparison of upper eyelid involutional ptosis repair techniques: efficacy and complication rates. Plast Reconstr Surg. 2012 Jan;129(1):149-157. doi: 10.1097/PRS.0b013e318230a1c7.
PubMed 22186506Sohrab MA, Lissner GS. Comparison of Fasanella-Servat and Small-Incision Techniques for Involutional Ptosis Repair. Ophthalmic Plast Reconstr Surg. 2016 Mar-Apr;32(2):98-101. doi: 10.1097/IOP.0000000000000417.
PubMed 25719375Ben Simon GJ, Joseph J, Lee S, Schwarcz RM, McCann JD, Goldberg RA. External versus endoscopic dacryocystorhinostomy for acquired nasolacrimal duct obstruction in a tertiary referral center. Ophthalmology. 2005 Aug;112(8):1463-8. doi: 10.1016/j.ophtha.2005.03.015.
PubMed 15953636Liu D. Ptosis repair by single suture aponeurotic tuck. Surgical technique and long-term results. Ophthalmology. 1993 Feb;100(2):251-9. doi: 10.1016/s0161-6420(93)31662-3.
PubMed 8437835
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Different Surgical Approaches for the Treatment of INVOLUTIONAL PTOSIS
- ClinicalTrials.gov ID
- NCT03373812
- Acronym / sponsor ID
- MMC17230-17CTIL
- Conditions
- Involutional Ptosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 14 Dec 2017 (actual)
- 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.
Involutional ptosis is a known eyelid pathology in which the eyelid margin obscures part of the visual axis (MRD1).Patients usually complains of visual field disturbance, deterioration in quality of life and a poor cosmetic appearance.
In clinical practice, two main surgical approaches are performed to the repair of involutional ptosis:
- anterior approach - skin incision and levator muscle insertion advancement.
- posterior approach - eyelid reversion and tarsectomy Both approaches has its pro's and con's, but to this date, no solid evidence exists to prove which of these techniques is superior in manner of anatomical and functional results. in this prospective study, patients with involutional ptosis will be randomized to each of surgical approaches groups, parameters concerning surgical and post surgical periods will be evaluated.
Detailed description
Involutional ptosis is a known eyelid pathology in which the eyelid margin obscures part of the visual axis (MRD1).Patients usually complains of visual field disturbance, deterioration in quality of life and a poor cosmetic appearance.
In clinical practice, two main surgical approaches are performed to the repair of involutional ptosis:
- anterior approach - skin incision and levator muscle insertion advancement.
- posterior approach - eyelid reversion and tarsectomy Both approaches has its pro's and con's, but to this date, no solid evidence exists to prove which of these techniques is superior in manner of anatomical and functional results. in this prospective study, patients with involutional ptosis will be randomized to each of surgical approaches groups, parameters concerning surgical and post surgical periods will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anterior approach | Active comparator | Procedure: Blepharoptosis repairpatients having involutional ptosis undergoing anterior approach surgical ptosis repair (Levator advancement) |
| posterior approach | Active comparator | Procedure: Blepharoptosis repairpatients having involutional ptosis undergoing posterior approach surgical ptosis repair (mullerectomy) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Involutional ptosis
- No previous eyelid surgery
Key exclusion criteria (4 listed)
- Previous eyelid surgery or trauma
- Congenital ptosis
- Previous glaucoma filtrartion surgery
- Unwillingness for six months followup
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 |
|---|---|---|
| Blepharoptosis repairlevator advancement or mullerectomy | Procedure or surgery | anterior approach, posterior approach |
Primary outcome
MRD1
Time frame: 6 months
Distance in millimeters between corneal light reflex and upper eyelid margin
surgery duration
Time frame: 3 hours
Time from first incision to last suture (in minutes)
Levator function
Time frame: 6 months
change (in millimeters) in upper eyelid position from downgaze to maximal upgaze
2 secondary outcomes
Need for additional eyelid surgery
Time frame: 6 months
Eyelid or ocular secondary disease
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 14 Dec 2017.
- Background: PubMed 27429227Patel RM, Aakalu VK, Setabutr P, Putterman AM. Efficacy of Muller's Muscle and Conjunctiva Resection With or Without Tarsectomy for the Treatment of Severe Involutional Blepharoptosis. Ophthalmic Plast Reconstr Surg. 2017 Jul/Aug;33(4):273-278. doi: 10.1097/IOP.0000000000000748.
- Background: PubMed 22186506Chang S, Lehrman C, Itani K, Rohrich RJ. A systematic review of comparison of upper eyelid involutional ptosis repair techniques: efficacy and complication rates. Plast Reconstr Surg. 2012 Jan;129(1):149-157. doi: 10.1097/PRS.0b013e318230a1c7.
- Background: PubMed 25719375Sohrab MA, Lissner GS. Comparison of Fasanella-Servat and Small-Incision Techniques for Involutional Ptosis Repair. Ophthalmic Plast Reconstr Surg. 2016 Mar-Apr;32(2):98-101. doi: 10.1097/IOP.0000000000000417.
- Background: PubMed 15953636Ben Simon GJ, Joseph J, Lee S, Schwarcz RM, McCann JD, Goldberg RA. External versus endoscopic dacryocystorhinostomy for acquired nasolacrimal duct obstruction in a tertiary referral center. Ophthalmology. 2005 Aug;112(8):1463-8. doi: 10.1016/j.ophtha.2005.03.015.
- Background: PubMed 8437835Liu D. Ptosis repair by single suture aponeurotic tuck. Surgical technique and long-term results. Ophthalmology. 1993 Feb;100(2):251-9. doi: 10.1016/s0161-6420(93)31662-3.
- Individual participant dataSharing planned: No
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.
Arie Nemet, Prof. (MD) principal investigator
ophthalmology depertmant, MeirMc, Israel
Questions about this trial
What is this clinical trial studying?
A study testing Blepharoptosis repair in people with Involutional Ptosis, run by Meir Medical Center.
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 4 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 14 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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 Arie Nemet, Prof. (MD) (+972-9-7471527, nemet.arik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRD1 (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03373812, which also lists 5 linked publications.
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 14 Dec 2017.