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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:


Further study details as provided by Azienda Policlinico Umberto I:

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00461435     History of Changes
Other Study ID Numbers: SS01
Study First Received: April 17, 2007
Last Updated: April 17, 2007

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 June 22, 2017