Down's SyndromeNCT01758718
Eyelash Line Resection for Entropion Associated With Down's Syndrome
A study testing Eyelash line resection in people with Down's Syndrome, run by Kyorin University at 1 site in Japan.
Trial summary
Surgical outcome of entropion associated with Down's syndrome was evaluated. Grading scale of superficial punctate keratopathy and score of wearing glasses to correct refractive errors were measured. Read more about this study
- Who is it for?
- Ages 3 to 90 years
- Conditions the study is for
- Down's Syndrome
- What is being tested?
- Eyelash line resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2007to Oct 2012
- 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 3 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patients with entropion with Down's syndrome
Who cannot join
- The patients of Down's syndrome who do not have entropion.
Trial locations and contacts
1 site in 1 country.
About this study
Surgical outcome of entropion associated with Down's syndrome was evaluated. Grading scale of superficial punctate keratopathy and score of wearing glasses to correct refractive errors were measured.
- Conditions
- Down's Syndrome
- Being tested
- Eyelash line resection
- Keywords
- Down's syndrome, entropion, lid plasty
- Medical subject headings
- Down Syndrome, Entropion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eyelash line resectionProcedure or surgery
Also called Lid plastic surgery
Eyelash resection surgery was performed for entropion with Down's syndrome
| Study group | Role | What they receive |
|---|---|---|
| Entropion with Down's syndrome | Active comparator | Eyelash resection surgery was performed for entropion with Down's syndrome Receives: Procedure: Eyelash line resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grading scale of superficial punctate keratopathy
The degree of superficial punctate keratopathy was assessed by the area and density classification which was scored with the area of superficial punctate keratopathy graded from A0 through A3, and the density graded from D0 through D3.
Measured: one year
Secondary outcomes (1)
Score of wearing glasses
The score of wearing glasses was graded 2; all day, 1; more than half day, 0; none of the day.
Measured: one ear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startApr 2007
- Primary completionMar 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Down's SyndromeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyorin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Makoto Inoue, Kyorin University
- Investigators
- Akito Hirakata, MD, Study chair, Kyorin Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758718
- Sponsor's protocol ID
- Kyorineye009
- Other IDs
- Entropion with Down's syndrome
- Status last verified
- Dec 2012
- First submitted
- 27 Dec 2012
- Last updated
- 1 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Suzuki Y, Hama Y, Yoshikawa-Kobayashi I, Tomita K, Inoue M, Hirakata A. Eyelash line resection for cilial entropion in patients with Down's syndrome. Br J Ophthalmol. 2014 Oct;98(10):1442-7. doi: 10.1136/bjophthalmol-2014-304946. Epub 2014 May 15.
PubMed 24831720
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eyelash Line Resection for Entropion Associated With Down's Syndrome
- ClinicalTrials.gov ID
- NCT01758718
- Acronym / sponsor ID
- Kyorineye009
- Conditions
- Down's Syndrome
- Keywords
- Down's syndrome, entropion, lid plasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Kyorin UniversityUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Mar 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 1 Jan 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.
Surgical outcome of entropion associated with Down's syndrome was evaluated. Grading scale of superficial punctate keratopathy and score of wearing glasses to correct refractive errors were measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Entropion with Down's syndrome | Active comparator | Procedure: Eyelash line resectionEyelash resection surgery was performed for entropion with Down's syndrome |
Who may qualify
- Ages
- 3 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The patients with entropion with Down's syndrome
Key exclusion criteria (1 listed)
- The patients of Down's syndrome who do not have entropion.
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 |
|---|---|---|
| Eyelash line resectionAlso: Lid plastic surgeryEyelash resection surgery was performed for entropion with Down's syndrome | Procedure or surgery | Entropion with Down's syndrome |
Primary outcome
Grading scale of superficial punctate keratopathy
Time frame: one year
The degree of superficial punctate keratopathy was assessed by the area and density classification which was scored with the area of superficial punctate keratopathy graded from A0 through A3, and the density graded from D0 through D3.
1 secondary outcome
Score of wearing glasses
Time frame: one ear
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 1 Jan 2013.
- Derived from this study: PubMed 24831720Suzuki Y, Hama Y, Yoshikawa-Kobayashi I, Tomita K, Inoue M, Hirakata A. Eyelash line resection for cilial entropion in patients with Down's syndrome. Br J Ophthalmol. 2014 Oct;98(10):1442-7. doi: 10.1136/bjophthalmol-2014-304946. Epub 2014 May 15.
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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.
Akito Hirakata, MD study chair
Kyorin Eye 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 Eyelash line resection in people with Down's Syndrome, run by Kyorin University at 1 site in Japan.
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: finished, as of the sponsor's last update on 1 Jan 2013. 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 Japan. 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?
Grading scale of superficial punctate keratopathy (time frame: one year). 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 NCT01758718, which also lists 1 linked publication.
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 1 Jan 2013.