Slowing the Degenerative Process, Long Lasting Effect of Hyperbaric Oxygen Therapy in Retinitis Pigmentosa

This study has been completed.

Sponsor:

Information provided by:

Azienda Policlinico Umberto I

ClinicalTrials.gov Identifier:

NCT00461435

First received: April 17, 2007

Last updated: NA

Last verified: April 2007

History: No changes posted

Purpose

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.

Condition	Intervention
Retinitis Pigmentosa	Procedure: hyperbaric oxygen therapy

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind
Official Title:	Slowing the Degenerative Process, Long Lasting Effect of Hyperbaric Oxygen Therapy in Retinitis Pigmentosa

Resource links provided by NLM:

Genetics Home Reference related topics: Lenz microphthalmia syndrome oculofaciocardiodental syndrome Peters plus syndrome retinitis pigmentosa X-linked juvenile retinoschisis

MedlinePlus related topics: Oxygen Therapy

U.S. FDA Resources

Further study details as provided by Azienda Policlinico Umberto I:

Eligibility

Ages Eligible for Study:	20 Years to 70 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Exclusion criteria were: patients with sporadic RP; BCVA ≤ 0.50 logMAR; visual field ≤ 3 degree diameter circle; not recordable ERG.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00461435

Locations

Italy
Azienda Policlinico Umberto I
Rome, Italy, 00161

Sponsors and Collaborators

Azienda Policlinico Umberto I

Investigators

Principal Investigator:

Enzo Maria Vingolo, PH.D.

Policlinico Umberto I, Dipartimento di Oftalmologia

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00461435 History of Changes
Other Study ID Numbers:	SS01
Study First Received:	April 17, 2007
Last Updated:	April 17, 2007
Health Authority:	Italy:Italian National commitee for hyperbaric therapy

Additional relevant MeSH terms:

Retinitis
Retinitis Pigmentosa
Retinal Diseases
Eye Diseases

Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on May 16, 2013

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