Ptosis, EyelidPhase 4NCT00753831
Efficacy of Aurosling in Frontalis Sling Suspension Surgery
A Phase 4 study testing Aurosling in people with Ptosis, Eyelid, run by Aurolab at 1 site in India.
Trial summary
To Study the Efficacy of Aurosling as a suspension material in Frontalis suspension surgery in ptosis Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ptosis, Eyelid
- What is being tested?
- Aurosling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2009to Aug 2009
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Congenital Ptosis
- Severe Ptosis (MRD<0)
- Poor levator function (<4mm by Berke's method)
- Myogenic Ptosis (Myasthenia gravis)
- Chronic progressive external ophthalmoplegia
- Neurogenic Ptosis (Third cranial palsy)
- Blepharospasm
- Ptosis caused by trauma
Who cannot join
- Acquired Ptosis
- Horners syndrome
- Blepharochalasis/Dermatochalasis
- Mechanical Ptosis
- Mild or Moderate Ptosis (MRD 1>1)
- Good or fair levator function (>4 mm by Berke's method)
Show all 15Show fewer
- Previous Ptosis surgery
- Ptosis associated syndromes/Other anomalies including
- Marcus Gunn jaw winking syndrome
- Blepharophimosis syndrome
- Dry eye syndromes
- Corneal anesthesia
- Medical/Pediatric/Anesthesia condition contraindicating to surgery or anesthesia
- Nystagmus where adequate measurements could not be done
- Uncorrected vertical squint of any sort
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double Blind, Active Controlled Study of the Efficacy, Surgical Outcome and Complications of Silicone Rod Sling in Frontalis Sling Suspension Surgery
To Study the Efficacy of Aurosling as a suspension material in Frontalis suspension surgery in ptosis
Read the detailed description
Silicon rod is an effective and safe material used in frontalis suspension in treating ptosis with poor levator function.The elasticity and ease of adjustment of silicon rod are ideal characteristics for suspension material used to treat severe ptosis in patients with poor bells phenomenon. In the present study , we attend to study the efficacy of aurosling silicon material as a suspension material for frontalis sling surgery
- Conditions
- Ptosis, Eyelid
- Being tested
- Aurosling
- Keywords
- Blepharoptosis, Ophthalmoplegia, Blepharospasm
- Medical subject headings
- Blepharoptosis, Ophthalmoplegia, Blepharospasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AuroslingProcedure or surgery
Silicon rod to be used in frontalis suspension surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Aurosling Receives: Procedure: Aurosling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ptosis Correction
Measured: 15th day, 90th day postoperatively
Secondary outcomes (1)
Adverse Events
Measured: 15th day, 90th day postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2008 (estimated)
- Study startJan 2009
- Primary completionJul 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ptosis, EyelidStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aurolab
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Usha Kim, DO, Dip NB, Principal investigator, Aravind Eye Hospital, Madurai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00753831
- Sponsor's protocol ID
- 2PR1220827
- Status last verified
- Jul 2012
- First submitted
- 16 Sep 2008
- Last updated
- 12 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Active Controlled Study of the Efficacy, Surgical Outcome and Complications of Silicone Rod Sling in Frontalis Sling Suspension Surgery
- ClinicalTrials.gov ID
- NCT00753831
- Acronym / sponsor ID
- 2PR1220827
- Conditions
- Ptosis, Eyelid
- Keywords
- Blepharoptosis, Ophthalmoplegia, Blepharospasm
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AurolabUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 17 Sep 2008 (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.
To Study the Efficacy of Aurosling as a suspension material in Frontalis suspension surgery in ptosis
Detailed description
Silicon rod is an effective and safe material used in frontalis suspension in treating ptosis with poor levator function.The elasticity and ease of adjustment of silicon rod are ideal characteristics for suspension material used to treat severe ptosis in patients with poor bells phenomenon. In the present study , we attend to study the efficacy of aurosling silicon material as a suspension material for frontalis sling surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: AuroslingAurosling |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Congenital Ptosis
- Severe Ptosis (MRD<0)
- Poor levator function (<4mm by Berke's method)
- Myogenic Ptosis (Myasthenia gravis)
- Chronic progressive external ophthalmoplegia
Key exclusion criteria (15 listed)
- Acquired Ptosis
- Horners syndrome
- Blepharochalasis/Dermatochalasis
- Mechanical Ptosis
- Mild or Moderate Ptosis (MRD 1>1)
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 |
|---|---|---|
| AuroslingSilicon rod to be used in frontalis suspension surgery | Procedure or surgery | 1 |
Primary outcome
Ptosis Correction
Time frame: 15th day, 90th day postoperatively
1 secondary outcome
Adverse Events
Time frame: 15th day, 90th day 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 12 Jul 2012.
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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.
Usha Kim, DO, Dip NB principal investigator
Aravind Eye Hospital, Madurai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aurosling in people with Ptosis, Eyelid, run by Aurolab at 1 site in India.
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 8 inclusion and 15 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 12 Jul 2012. 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 India. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Ptosis Correction (time frame: 15th day, 90th day 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 12 Jul 2012.