Retinitis PigmentosaNCT00784901
Study of the Correlation Between Macular Thickness Analyzed by Optical Coherence Tomography and the Visual Functions in Retinitis Pigmemtosa
An observational study of Retinitis Pigmentosa, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Purpose: To study the associations between visual functions and the retinal tomography detected by optical coherence tomography (OCT) in patients with retinitis pigmentosa (RP). Study design: retrospective, non-randomized and non-comparable study Material: Medical recordings of the RP patients who visited the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinitis Pigmentosa
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2008to Nov 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Medical recordings of the RP patients who visited the Out-Patient Department of Ophthalmology in NTUH during June, 2003 to June, 2008
Who may be able to join
- Medical recordings of the RP patients who visited the Out-Patient Department of Ophthalmology in NTUH during June, 2003 to June, 2008
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Purpose: To study the associations between visual functions and the retinal tomography detected by optical coherence tomography (OCT) in patients with retinitis pigmentosa (RP).
Study design: retrospective, non-randomized and non-comparable study Material: Medical recordings of the RP patients who visited the Out-Patient Department of Ophthalmology in NTUH during June, 2003 to June, 2008.
Read more
Methods: By reviewing charts of the RP patients, the investigators will categorize RP patients into different types according to the loci of the pathological change in their retina evaluated by opththaomoscopy. And the investigators will collect the data of their visual functions including visual acuity, visual field, Arden ratio of electrooculography, and color sense discrimination. Then, according to the OCT map, the investigators will analyze the retinal thickness by dividing the macular area into foveal area, inner ring and outer ring. Finally, the investigators will analyze the relationships between visual functions and retinal thickness in different macular areas in different types of RP patients.
Anticipated results: The investigators expect that retinal tomographies may different among different types of RP. And the retinal tomographic change may correspond to the change of a certain kind of visual function. Hence, according to the thickness of a specific area in macula, the investigators may anticipate that some visual dysfunction may exist.
Read the detailed description
The diagnosis of RP was according to the typical clinical history of night blindness, characteristically findings of "bone-spicule" change in the fundus, and varying degrees of peripheral visual field constriction. According to the affected loci in the fundus, we defined a typical type of RP as the retinal pathological change was around the banded area outside the main vascular arcs, and a central variant of RP stood for those with bone-spicule change appeared at the macula.[17] The exclusion criteria included eyes with histories of trauma, intraocular laser treatment, intraocular surgery, presence of retinal diseases, high degree of myopia with refraction more minus than -8.0 D or hyperopia with refraction more than +5.0 D. Patients with systemic diseases that may affect retina like diabetes or hypertension were also excluded.
Visual acuity was examined with a Snellen visual chart with a calibrated luminance. Then according to the equation that Snellen VA equals to 1/MAR (MAR= minimal angle of resolution), Snellen VA was converted into logMAR for statistics. For calculation, visual acuity of hand motion was converted into 20/2000 and light perception was converted into 20/20000 of Snellen fraction. Visula field examination was evaluated using Goldmann kinetic perimetry with varying sizes and illuminations of testing light spots. Then the degree of the widest visual field isopter was recorded. EOG: is used to assess function of retinal pigment epithelium. During dark adaptation, resting potential decreases slightly and reaches a minimum ("dark trough"). When the light is on, the resting potential increases ("light peak"). The ratio of light peak voltage versus dark trough voltage is known as the Arden ratio. The EOG was performed with pupil dilated, first in the dark for 15 minutes, and then in the light for 15 minutes and the Arden ratio for analysis was recorded.
Color sense discrimination test was evaluated using Farnsworth Munsell 100-Hue test (Munsell FM 100, X-Rite, USA). Each patient arranged four trays of colored caps in hue order. There is a predetermined sequence for each tray. The closer the patient's arrangement is to the correct sequence, the better the patient's color sense discrimination. The Farnsworth-Munsell 100-Hue Test Scoring Software was used to score the results of Farnsworth-Munsell 100-Hue Test. The results are displayed in polar or linear format, and the total error score was recorded for calculation.
OCT was performed with the ultimate commercial OCT units (OCT3, Carl Zeiss Meditec, Inc, Dublin, CA) to measure the macular thickness under papillary dilatation by an experienced examiner. The retinal thickness was calculated using OCT retinal mapping software (version 6.1 a), which measured thickness of nine divided macular regions after six scans with 6 mm long centered on the patient's fixation point by means of an inner fixation target (Figure 1), and expressed as a color-coded map. Internal fixation was essentially chosen due to better reproducibility. We defined the foveal area as the area centered at fixation with a diameter of one millimeter, the inner ring as the area between circles with diameter of one and three millimeters, and outer ring as the area between circles with diameter of three and six millimeters (Figure 2).
We analyzed and compared the patients' characteristics, results of visual function tests and macular tomography in these two groups of RP. Then we tried to find out if there were correlations between macular tomography and visual function tests
- Conditions
- Retinitis Pigmentosa
- Keywords
- Macular Thickness Analyzed by Optical Coherence Tomography in Retinitis Pigmemtosa
- Medical subject headings
- Retinitis Pigmentosa
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2008 (estimated)
- Study startAug 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinitis PigmentosaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Muh Shy Chen, Professor, Study chair, NTUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00784901
- Sponsor's protocol ID
- 200807069R
- Status last verified
- Nov 2008
- First submitted
- 2 Nov 2008
- Last updated
- 11 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Correlation Between Macular Thickness Analyzed by Optical Coherence Tomography and the Visual Functions in Retinitis Pigmemtosa
- ClinicalTrials.gov ID
- NCT00784901
- Acronym / sponsor ID
- 200807069R
- Conditions
- Retinitis Pigmentosa
- Keywords
- Macular Thickness Analyzed by Optical Coherence Tomography in Retinitis Pigmemtosa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 4 Nov 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.
Purpose: To study the associations between visual functions and the retinal tomography detected by optical coherence tomography (OCT) in patients with retinitis pigmentosa (RP).
Study design: retrospective, non-randomized and non-comparable study Material: Medical recordings of the RP patients who visited the Out-Patient Department of Ophthalmology in NTUH during June, 2003 to June, 2008.
Methods: By reviewing charts of the RP patients, the investigators will categorize RP patients into different types according to the loci of the pathological change in their retina evaluated by opththaomoscopy. And the investigators will collect the data of their visual functions including visual acuity, visual field, Arden ratio of electrooculography, and color sense discrimination. Then, according to the OCT map, the investigators will analyze the retinal thickness by dividing the macular area into foveal area, inner ring and outer ring. Finally, the investigators will analyze the relationships between visual functions and retinal thickness in different macular areas in different types of RP patients.
Anticipated results: The investigators expect that retinal tomographies may different among different types of RP. And the retinal tomographic change may correspond to the change of a certain kind of visual function. Hence, according to the thickness of a specific area in macula, the investigators may anticipate that some visual dysfunction may exist.
Detailed description
The diagnosis of RP was according to the typical clinical history of night blindness, characteristically findings of "bone-spicule" change in the fundus, and varying degrees of peripheral visual field constriction. According to the affected loci in the fundus, we defined a typical type of RP as the retinal pathological change was around the banded area outside the main vascular arcs, and a central variant of RP stood for those with bone-spicule change appeared at the macula.[17] The exclusion criteria included eyes with histories of trauma, intraocular laser treatment, intraocular surgery, presence of retinal diseases, high degree of myopia with refraction more minus than -8.0 D or hyperopia with refraction more than +5.0 D. Patients with systemic diseases that may affect retina like diabetes or hypertension were also excluded.
Visual acuity was examined with a Snellen visual chart with a calibrated luminance. Then according to the equation that Snellen VA equals to 1/MAR (MAR= minimal angle of resolution), Snellen VA was converted into logMAR for statistics. For calculation, visual acuity of hand motion was converted into 20/2000 and light perception was converted into 20/20000 of Snellen fraction. Visula field examination was evaluated using Goldmann kinetic perimetry with varying sizes and illuminations of testing light spots. Then the degree of the widest visual field isopter was recorded. EOG: is used to assess function of retinal pigment epithelium. During dark adaptation, resting potential decreases slightly and reaches a minimum ("dark trough"). When the light is on, the resting potential increases ("light peak"). The ratio of light peak voltage versus dark trough voltage is known as the Arden ratio. The EOG was performed with pupil dilated, first in the dark for 15 minutes, and then in the light for 15 minutes and the Arden ratio for analysis was recorded.
Color sense discrimination test was evaluated using Farnsworth Munsell 100-Hue test (Munsell FM 100, X-Rite, USA). Each patient arranged four trays of colored caps in hue order. There is a predetermined sequence for each tray. The closer the patient's arrangement is to the correct sequence, the better the patient's color sense discrimination. The Farnsworth-Munsell 100-Hue Test Scoring Software was used to score the results of Farnsworth-Munsell 100-Hue Test. The results are displayed in polar or linear format, and the total error score was recorded for calculation.
OCT was performed with the ultimate commercial OCT units (OCT3, Carl Zeiss Meditec, Inc, Dublin, CA) to measure the macular thickness under papillary dilatation by an experienced examiner. The retinal thickness was calculated using OCT retinal mapping software (version 6.1 a), which measured thickness of nine divided macular regions after six scans with 6 mm long centered on the patient's fixation point by means of an inner fixation target (Figure 1), and expressed as a color-coded map. Internal fixation was essentially chosen due to better reproducibility. We defined the foveal area as the area centered at fixation with a diameter of one millimeter, the inner ring as the area between circles with diameter of one and three millimeters, and outer ring as the area between circles with diameter of three and six millimeters (Figure 2).
We analyzed and compared the patients' characteristics, results of visual function tests and macular tomography in these two groups of RP. Then we tried to find out if there were correlations between macular tomography and visual function tests
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Medical recordings of the RP patients who visited the Out-Patient Department of Ophthalmology in NTUH during June, 2003 to June, 2008
Key inclusion criteria (1 listed)
- Medical recordings of the RP patients who visited the Out-Patient Department of Ophthalmology in NTUH during June, 2003 to June, 2008
Key exclusion criteria (0 listed)
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 11 Nov 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.
Muh Shy Chen, Professor study chair
NTUH
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 Retinitis Pigmentosa, run by National Taiwan University 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 1 inclusion and 0 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 11 Nov 2008. 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?
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 11 Nov 2008.