AnisometropiaPhase 4NCT00800774
Ten-year Follow-up of Laser in Situ Keratomileusis in Patients 8 to 15 Years Old
A Phase 4 study testing LASIK in people with Anisometropia, run by Instituto de Olhos de Goiania at 1 site in Brazil.
Trial summary
The purpose of this study is to determine the safety, efficacy, predictability, and stability of laser in situ keratomileusis (LASIK) to correct high anisometropia in patients 8 to 15 years old in whom conventional treatments have failed. Read more about this study
- Who is it for?
- Ages 8 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Anisometropia
- What is being tested?
- LASIK
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 1998to Sep 2008
- 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 8 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- High anisometropia (>3.50 D)
- Patients 8 to 15 years old
- Conventional treatments have failed
Who cannot join
- Diabetes
- Autoimmune diseases
- Topographic abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the safety, efficacy, predictability, and stability of laser in situ keratomileusis (LASIK) to correct high anisometropia in patients 8 to 15 years old in whom conventional treatments have failed.
Read the detailed description
Nine eyes of nine patients (3 male and 6 female) with high anisometropia (>3.50 D), were included in this study. Minimum follow-up was 10 years. All patients were treated with the Chiron Technolas 217 excimer laser.
- Conditions
- Anisometropia
- Being tested
- LASIK
- Keywords
- LASIK, safety, efficacy, stability, high anisometropia, patients 8 to 15 years old, conventional treatments have failed
- Medical subject headings
- Anisometropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LASIKProcedure or surgery
Nine eyes of nine patients (3 male and 6 female) with high anisometropia (>3.50 D), were included in this study. Minimum follow-up was 10 years. All patients were treated with the Chiron Technolas 217 excimer laser.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Nine eyes of nine patients (3 male and 6 female) with high anisometropia (>3.50 D), were included in this study. Minimum follow-up was 10 years. All patients were treated with the Chiron Technolas 217 excimer laser. Receives: Procedure: LASIK |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2008 (estimated)
- Study startJan 1998
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnisometropiaStudies 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Olhos de Goiania
- Sponsor type
- University, hospital or other
- Investigators
- Belquiz A Nassaralla, MD, PhD, Study chair, Instituto de Olhos de Goiania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800774
- Sponsor's protocol ID
- ARVO - BN - 2009
- Status last verified
- Sep 2008
- First submitted
- 1 Dec 2008
- Last updated
- 25 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ten-year Follow-up of Laser in Situ Keratomileusis in Patients 8 to 15 Years Old
- ClinicalTrials.gov ID
- NCT00800774
- Acronym / sponsor ID
- ARVO - BN - 2009
- Conditions
- Anisometropia
- Keywords
- LASIK, safety, efficacy, stability, high anisometropia, patients 8 to 15 years old, conventional treatments have failed
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Instituto de Olhos de GoianiaUniversity, hospital or other
- Study start
- Jan 1998
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 2 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 purpose of this study is to determine the safety, efficacy, predictability, and stability of laser in situ keratomileusis (LASIK) to correct high anisometropia in patients 8 to 15 years old in whom conventional treatments have failed.
Detailed description
Nine eyes of nine patients (3 male and 6 female) with high anisometropia (>3.50 D), were included in this study. Minimum follow-up was 10 years. All patients were treated with the Chiron Technolas 217 excimer laser.
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: LASIKNine eyes of nine patients (3 male and 6 female) with high anisometropia (>3.50 D), were included in this study. Minimum follow-up was 10 years. All patients were treated with the Chiron Technolas 217 excimer laser. |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- High anisometropia (>3.50 D)
- Patients 8 to 15 years old
- Conventional treatments have failed
Key exclusion criteria (3 listed)
- Diabetes
- Autoimmune diseases
- Topographic abnormalities
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 |
|---|---|---|
| LASIKNine eyes of nine patients (3 male and 6 female) with high anisometropia (>3.50 D), were included in this study. Minimum follow-up was 10 years. All patients were treated with the Chiron Technolas 217 excimer laser. | Procedure or surgery | 1 |
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 25 Nov 2009.
Related trials for Anisometropia
RecruitingPhase 1/2
Psilocybin for Amblyopia - Targeting Critical Periods in Humans
Amblyopia
Not yet recruiting
The EYERISING Study
Myopia, Astigmatism
Recruiting
Targeted Lens Intervention for Myopic Anisometropia in Children
Anisometropia, Myopia
Not yet recruiting
Attention-based Binocular Training for Impaired Stereopsis (BRAVE)
Amblyopia, Strabismus
Not yet recruitingObservational study
Children Receiving Monocular MiSight® 1 Day Treatment for Unilateral Myopia
Myopia (Disorder), Anisometropia
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.
Belquiz A Nassaralla, MD, PhD study chair
Instituto de Olhos de Goiania
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 LASIK in people with Anisometropia, run by Instituto de Olhos de Goiania at 1 site in Brazil.
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 3 inclusion and 3 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 25 Nov 2009. 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 Brazil. 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.
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 25 Nov 2009.