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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Taiwan1 site
  • Naitonal Taiwan University Hospital

    Taipei, 100

Other trials in Taiwan

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

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.

  1. First posted4 Nov 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionNov 2008
  4. Study completionNov 2008

Resources

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)
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

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.

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