Malposition of the Lower LidNCT01054157
Expression and Localization of FP Prostaglandin Receptor in Human Ocular Tissues
An observational study of Malposition of the Lower Lid, run by Meir Medical Center.
Trial summary
to approve the expression of PGF2α receptors in hair follicle in ocular skin tissue, explaining the hypertrichotic effect of PG analogues as intraocular pressure lowering treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malposition of the Lower Lid
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: human lower lid skin and lashes will be derived from lateral tarsal strip (LTS) dissected routinely in ectropion repair surgery, the skin strip is dissected routinely in this surgery
Who may be able to join
- age > 18 years
- malposition of lower eyelid
Who cannot join
- age < 18 years
About this study
to approve the expression of PGF2α receptors in hair follicle in ocular skin tissue, explaining the hypertrichotic effect of PG analogues as intraocular pressure lowering treatment.
Read the detailed description
50 hair follicle dissection - human lower lid skin and lashes will be derived from lateral tarsal strip (LTS) dissected routinely in ectropion repair surgery, the skin strip is dissected routinely in this surgery , without any relation to our study. The study will be planned according to Helsinki declaration for Paraffin embedded LTS tissue sections (4 µ) will be processed and examined in immunohistochemistry lab. FP receptor proteins expression, using subtype-specific polyclonal antibodies, will be detected by the light microscopic level, according to manufacturer instruction.
- Conditions
- Malposition of the Lower Lid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malposition of the Lower LidStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- halah el naddaf, doctor, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01054157
- Sponsor's protocol ID
- PROST-1
- Status last verified
- Jan 2010
- First submitted
- 21 Jan 2010
- Last updated
- 22 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression and Localization of FP Prostaglandin Receptor in Human Ocular Tissues
- ClinicalTrials.gov ID
- NCT01054157
- Acronym / sponsor ID
- PROST-1
- Conditions
- Malposition of the Lower Lid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Feb 2010
- First posted
- 22 Jan 2010 (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 approve the expression of PGF2α receptors in hair follicle in ocular skin tissue, explaining the hypertrichotic effect of PG analogues as intraocular pressure lowering treatment.
Detailed description
50 hair follicle dissection - human lower lid skin and lashes will be derived from lateral tarsal strip (LTS) dissected routinely in ectropion repair surgery, the skin strip is dissected routinely in this surgery , without any relation to our study. The study will be planned according to Helsinki declaration for Paraffin embedded LTS tissue sections (4 µ) will be processed and examined in immunohistochemistry lab. FP receptor proteins expression, using subtype-specific polyclonal antibodies, will be detected by the light microscopic level, according to manufacturer instruction.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- human lower lid skin and lashes will be derived from lateral tarsal strip (LTS) dissected routinely in ectropion repair surgery, the skin strip is dissected routinely in this surgery
Key inclusion criteria (2 listed)
- age > 18 years
- malposition of lower eyelid
Key exclusion criteria (1 listed)
- age < 18 years
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2010.
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.
halah el naddaf, doctor principal investigator
Meir Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Malposition of the Lower Lid, 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 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: status not confirmed, as of the sponsor's last update on 22 Jan 2010. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 22 Jan 2010.