NCT00461435

Brief Summary

Our aim was to assess the role and usefulness of Hyperbaric oxygen therapy in a long lasting period, assessing its efficacy on rescuing retinal photoreceptors and preserving visual function in retinitis pigmentosa.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 18, 2007

Completed
Last Updated

April 18, 2007

Status Verified

April 1, 2007

First QC Date

April 17, 2007

Last Update Submit

April 17, 2007

Conditions

Retinitis Pigmentosa

Interventions

hyperbaric oxygen therapyPROCEDURE

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with clearly hereditary RP (we performed to all of them genetic analysis for rhodopsin, and peripherin genes, only 4 patient with ADRP showed point mutation 3 on codon 135 and 1 on codon 347); best corrected visual acuity (BCVA) ≥ 0.50 logMAR; visual field ≥ 3 degree diameter circle; recordable ERG.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Policlinico Umberto I

Rome, 00161, Italy

Location

MeSH Terms

Conditions

Retinitis Pigmentosa

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesRetinal DystrophiesRetinal DegenerationRetinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeutics

Study Officials

  • Enzo Maria Vingolo, PH.D.

    Policlinico Umberto I, Dipartimento di Oftalmologia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 17, 2007

First Posted

April 18, 2007

Last Updated

April 18, 2007

Record last verified: 2007-04

Locations

IT(1)