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NCT04561869
PIC and Its Role in Progression of Pathological Myopia
trial in Punctate Inner Choroidopathy in 39 participants. Status unknown.
15 October 2021
Quick facts
| Lead sponsor | Assiut University |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 39 |
| Start date | 15 October 2020 |
| Primary completion | 15 October 2021 |
| Estimated completion | 15 November 2021 |
| Sites | 1 location across Japan |
Conditions studied
- Punctate Inner Choroidopathy — all drugs for Punctate Inner Choroidopathy →
Sponsor
Assiut University
Who can join
Adults 18 to 80, any sex, with Punctate Inner Choroidopathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Aim of the work PIC in pathological myopia has not been well documented due to difficult in diagnosis we conducted this retrospective study to characterize the clinical features of PIC in high myopic eye. * To show the diagnostic criteria of PIC lesions in high myopic patients. * Find out the prevalence of PIC related 'patchy atrophy' * To determine risk factor for developed PIC in a series of highly myopic patients. * Role of PIC in progression of high myopia. * Calculate the progression rate of PIC related lesion, by the size change during follow-up. * Search about complication of PIC in myopia. Patient and Methods This retrospective observational case series study included patients with high myopia who had been examined and followed-up in the High Myopia Clinic of the Tokyo Medical and Dental University. Approval from Ethics Committee of Tokyo Medical and Dental University was obtained, adhering to the tenets of Declaration of Helsinki. Signed informed consent documentation was obtained from all participants. All study participants underwent a detailed ophthalmologic examination at baseline and at each follow-up visit. The examinations included measurements of best-corrected visual acuity (BCVA) using a Landolt C chart, refraction, slit lamp biomicroscopy, biometry for determination of axial length, (IOL Master; Carl Zeiss Meditec Co, Jena, Germany), fundus examination in medical mydriasis, fluorescein angiography, was performed with and colour fundus photography , and assessment of fundus autofluorescence (TRC-50DX; Topcon, Tokyo, Japan) a or the Heidelberg Spectralis HRA system. Swept source Optical coherence tomography (OCT) used in assessment of the RPE and photoreceptors using a (DRI-OCT;Topcon, Tokyo, Japan). As scanning protocols, 9 mm or 6 mm radial with 12 equal meridian scans were performed. The swept-source OCT device has an A-scan repetition rate of 100 000 Hz, and its light source operates in the wavelength range of 1 μm.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04561869 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assiut University
- Last refreshed: 18 June 2021
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