Eye Diseases, HereditaryNCT00811512
Fundus Changes in the Microphthalmy Eyes
An observational study of Eye Diseases, Hereditary, run by Hospital de Olhos Sadalla Amin Ghanem.
Trial summary
The goal is to describe the fundamental aspects of fundoscopic eye in patients with microphthalmia Read more about this study
- Who is it for?
- Ages 10 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Eye Diseases, Hereditary
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- May 2007to Oct 2008
- 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 10 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: the study is the description of three cases of microphthalmy with changes to fund of the eye, all documented with optical coherence tomography and clinical characteristics.
Who may be able to join
- Clinical diagnosis of microphthalmia
Who cannot join
- Eyes larger than 18mm
About this study
The goal is to describe the fundamental aspects of fundoscopic eye in patients with microphthalmia
Read the detailed description
Microphthalmos is a developmental ocular disorder defined as a small eyeball. The condition can be associated with abnormalities of anterior and posterior segments. The most common anterior characteristics include corneal opacities, angle-closure and a shallow anterior chamber and cataract. The main findings of posterior segment are uveal effusion, retinal folds, abnormalities of macular capillary vascularization, absence of foveal depression and peripheral retinoschisis. We performed on 3 patients with microphthalmos and their OCT features of posterior segment.
- Conditions
- Eye Diseases, Hereditary
- Keywords
- retina, fold, fovea
- Medical subject headings
- Eye Diseases, Hereditary
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2008 (estimated)
- Study startMay 2007
- Primary completionSep 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye Diseases, HereditaryStudies 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
- Retrospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Olhos Sadalla Amin Ghanem
- Sponsor type
- University, hospital or other
- Investigators
- Fernando J Novelli, Bsc, Principal investigator, Hospital de Olhos Sadalla Amin Ghanem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00811512
- Sponsor's protocol ID
- sadalla1
- Status last verified
- Dec 2008
- First submitted
- 18 Dec 2008
- Last updated
- 19 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fundus Changes in the Microphthalmy Eyes
- ClinicalTrials.gov ID
- NCT00811512
- Acronym / sponsor ID
- sadalla1
- Conditions
- Eye Diseases, Hereditary
- Keywords
- retina, fold, fovea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Hospital de Olhos Sadalla Amin GhanemUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 19 Dec 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.
The goal is to describe the fundamental aspects of fundoscopic eye in patients with microphthalmia
Detailed description
Microphthalmos is a developmental ocular disorder defined as a small eyeball. The condition can be associated with abnormalities of anterior and posterior segments. The most common anterior characteristics include corneal opacities, angle-closure and a shallow anterior chamber and cataract. The main findings of posterior segment are uveal effusion, retinal folds, abnormalities of macular capillary vascularization, absence of foveal depression and peripheral retinoschisis. We performed on 3 patients with microphthalmos and their OCT features of posterior segment.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- the study is the description of three cases of microphthalmy with changes to fund of the eye, all documented with optical coherence tomography and clinical characteristics.
Key inclusion criteria (1 listed)
- Clinical diagnosis of microphthalmia
Key exclusion criteria (1 listed)
- Eyes larger than 18mm
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
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 19 Dec 2008.
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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.
Fernando J Novelli, Bsc principal investigator
Hospital de Olhos Sadalla Amin Ghanem
Questions about this trial
What is this clinical trial studying?
An observational study of Eye Diseases, Hereditary, run by Hospital de Olhos Sadalla Amin Ghanem.
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 19 Dec 2008. 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?
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.
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 19 Dec 2008.