MyopiaNCT00838734
Compare Anterior Chamber Biometry in Healthy and Post-LASIK Patients
An observational study of Myopia and Astigmatism, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
In this study, the investigators employed Visante-OCT (Carl Zeiss, USA), an anterior chamber optical coherence tomography, to monitor the change of anterior chamber dimensions. These data were correlated to anterior and posterior curvature changes collected with the Oculus Pentacam (Oculus Inc., Germany), a corneal… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Astigmatism
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2008to Jun 2009
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteer
Who may be able to join
- healthy young volunteer who has not received any ocular surgery
- post-LASIK surgery young volunteers
- all participants has to be less than 35 years old.
Who cannot join
- any subject with contact lens history will be asked to stop contact lens wear for at least 4 weeks before participating in this study.
- any subject with prior ocular disease
- any subject with prior intra-ocular surgery
- any subject who cannot cooperate with examination
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Far Eastern Memorial Hospital
Banqiao District, Taipei, 220
Shu-Wen Chang, MD, 886-2-8966-7000, swchang@mail.femh.org.tw
About this study
Official title: Compare Anterior Chamber Biometry in Healthy and Post-LASIK Pati
In this study, the investigators employed Visante-OCT (Carl Zeiss, USA), an anterior chamber optical coherence tomography, to monitor the change of anterior chamber dimensions. These data were correlated to anterior and posterior curvature changes collected with the Oculus Pentacam (Oculus Inc., Germany), a corneal topographer based on rotating Scheimpflug principle. To minimize the effect of convergence and excyclotorsion during examination, topical cycloplegic medication was used. The investigators hypothesized that if there is a link between ciliary muscle contraction and cornea curvature, installation of cycloplegic should result in widening of anterior chamber angle to angle distance and flattening of the cornea curvature data.
Read the detailed description
Accommodation is an action that enables projections of both distant and near objects to be brought into clear focus on the retina through changing of diopteric power of crystalline lens. Although the exact mechanism of accommodation remains inconclusive, most authors agree that contraction of ciliary muscle plays a pivotal role.1, 2 Recently, accumulating evidence shows that the effect of ciliary muscle contraction goes beyond merely changing the curvature of the crystalline lens.3 Ciliary muscle contraction might be responsible for a transient elongation in axial length during the accommodation response.3 Contraction of ciliary smooth muscle applied an inward pulling force on the choroid and sclera adjacent to the ciliary body and cause protrusion at posterior sclera.
If ciliary muscle contraction can elicit protrusion at posterior sclera, it is conceivable that some changes in corneal shape would also occur as the cornea is adjacent to ciliary muscle. The influence of accommodation on the cornea has therefore been the subject of several studies with conflicting results. Some authors reported no change4, 5, while others described significant change in corneal curvature during accommodation6-9. Yasuda and Yamaguchi9 found central corneal steepening of approximately 0.10 D, using pharmacologically induced ciliary muscle contraction and corneal topography analysis. Saitoh et al10 reported that instillation of a sympathomimetic agent to stimulate mydriasis induces significant flattening of both anterior and posterior cornea curvatures as detected by Orbscan . On the contrary, Buehren5 and Read4 argue that changes in corneal topography is a result of excyclotorsional eye movement during accommodation. When this excyclotorsional eye movement was accounted for in their data analysis, no significant change in corneal topography was found with accommodation. The effect of ciliary relaxation on the cornea curvature, however, was less well delineated.
In this study, we employed Visante-OCT (Carl ZeiIn this study, we employed Visante-OCT (Carl Zeiss, USA), an anterior chamber optical coherence tomography, to monitor the change of anterior chamber dimensions. These data were correlated to anterior and posterior curvature changes collected with the Oculus Pentacam (Oculus Inc., Germany), a corneal topographer based on rotating Scheimpflug principle. To minimize the effect of convergence and excyclotorsion during examination, topical cycloplegic medication was used. We hypothesized that if there is a link between ciliary muscle contraction and cornea curvature, installation of cycloplegic should result in widening of anterior chamber angle to angle distance and flattening of the cornea curvature data.
ss, USA), an anterior chamber optical coherence tomography, to monitor the change of anterior chamber dimensions. These data were correlated to anterior and posterior curvature changes collected with the Oculus Pentacam (Oculus Inc., Germany), a corneal topographer based on rotating Scheimpflug principle. To minimize the effect of convergence and excyclotorsion during examination, topical cycloplegic medication was used. We hypothesized that if there is a link between ciliary muscle contraction and cornea curvature, installation of cycloplegic should result in widening of anterior chamber angle to angle distance and flattening of the cornea curvature data.
In addition, we would also compare the accuracy in pupil diameter measurements between Pentacam and Visante OCT under under normal and mydratic conditions.
- Conditions
- Myopia, Astigmatism
- Keywords
- CORNEAL TOPOGRAPHY, KERATOPLASTY
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Pre-LASIK | |
| 2 | Post-LASIK |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study startJun 2008
- Study completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Shu-Wen Chang, MD, Principal investigator, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838734
- Sponsor's protocol ID
- FEMH97011
- Status last verified
- Feb 2009
- First submitted
- 4 Feb 2009
- Last updated
- 6 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare Anterior Chamber Biometry in Healthy and Post-LASIK Pati
- ClinicalTrials.gov ID
- NCT00838734
- Acronym / sponsor ID
- FEMH97011
- Conditions
- Myopia, Astigmatism
- Keywords
- CORNEAL TOPOGRAPHY, KERATOPLASTY
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Jun 2008
- Study completion
- Jun 2009 (estimated)
- First posted
- 6 Feb 2009 (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.
In this study, the investigators employed Visante-OCT (Carl Zeiss, USA), an anterior chamber optical coherence tomography, to monitor the change of anterior chamber dimensions. These data were correlated to anterior and posterior curvature changes collected with the Oculus Pentacam (Oculus Inc., Germany), a corneal topographer based on rotating Scheimpflug principle. To minimize the effect of convergence and excyclotorsion during examination, topical cycloplegic medication was used. The investigators hypothesized that if there is a link between ciliary muscle contraction and cornea curvature, installation of cycloplegic should result in widening of anterior chamber angle to angle distance and flattening of the cornea curvature data.
Detailed description
Accommodation is an action that enables projections of both distant and near objects to be brought into clear focus on the retina through changing of diopteric power of crystalline lens. Although the exact mechanism of accommodation remains inconclusive, most authors agree that contraction of ciliary muscle plays a pivotal role.1, 2 Recently, accumulating evidence shows that the effect of ciliary muscle contraction goes beyond merely changing the curvature of the crystalline lens.3 Ciliary muscle contraction might be responsible for a transient elongation in axial length during the accommodation response.3 Contraction of ciliary smooth muscle applied an inward pulling force on the choroid and sclera adjacent to the ciliary body and cause protrusion at posterior sclera.
If ciliary muscle contraction can elicit protrusion at posterior sclera, it is conceivable that some changes in corneal shape would also occur as the cornea is adjacent to ciliary muscle. The influence of accommodation on the cornea has therefore been the subject of several studies with conflicting results. Some authors reported no change4, 5, while others described significant change in corneal curvature during accommodation6-9. Yasuda and Yamaguchi9 found central corneal steepening of approximately 0.10 D, using pharmacologically induced ciliary muscle contraction and corneal topography analysis. Saitoh et al10 reported that instillation of a sympathomimetic agent to stimulate mydriasis induces significant flattening of both anterior and posterior cornea curvatures as detected by Orbscan . On the contrary, Buehren5 and Read4 argue that changes in corneal topography is a result of excyclotorsional eye movement during accommodation. When this excyclotorsional eye movement was accounted for in their data analysis, no significant change in corneal topography was found with accommodation. The effect of ciliary relaxation on the cornea curvature, however, was less well delineated.
In this study, we employed Visante-OCT (Carl ZeiIn this study, we employed Visante-OCT (Carl Zeiss, USA), an anterior chamber optical coherence tomography, to monitor the change of anterior chamber dimensions. These data were correlated to anterior and posterior curvature changes collected with the Oculus Pentacam (Oculus Inc., Germany), a corneal topographer based on rotating Scheimpflug principle. To minimize the effect of convergence and excyclotorsion during examination, topical cycloplegic medication was used. We hypothesized that if there is a link between ciliary muscle contraction and cornea curvature, installation of cycloplegic should result in widening of anterior chamber angle to angle distance and flattening of the cornea curvature data.
ss, USA), an anterior chamber optical coherence tomography, to monitor the change of anterior chamber dimensions. These data were correlated to anterior and posterior curvature changes collected with the Oculus Pentacam (Oculus Inc., Germany), a corneal topographer based on rotating Scheimpflug principle. To minimize the effect of convergence and excyclotorsion during examination, topical cycloplegic medication was used. We hypothesized that if there is a link between ciliary muscle contraction and cornea curvature, installation of cycloplegic should result in widening of anterior chamber angle to angle distance and flattening of the cornea curvature data.
In addition, we would also compare the accuracy in pupil diameter measurements between Pentacam and Visante OCT under under normal and mydratic conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Pre-LASIK |
| 2 | – | –Post-LASIK |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteer
Key inclusion criteria (3 listed)
- healthy young volunteer who has not received any ocular surgery
- post-LASIK surgery young volunteers
- all participants has to be less than 35 years old.
Key exclusion criteria (4 listed)
- any subject with contact lens history will be asked to stop contact lens wear for at least 4 weeks before participating in this study.
- any subject with prior ocular disease
- any subject with prior intra-ocular surgery
- any subject who cannot cooperate with examination
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 6 Feb 2009.
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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.
Shu-Wen Chang, MD principal investigator
Far Eastern Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia and Astigmatism, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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 4 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 6 Feb 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shu-Wen Chang, MD (866-2-8966-7000 ext. 4271, swchang@mail.femh.org.tw), or a site near the patient. 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 6 Feb 2009.