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Retinal DetachmentPhase 2/3NCT00403702

Comparison High-density Silicone Oils in Retinal Detachment

A Phase 2/3 study testing Oxane HD [oil-RMN3-mixture] and Densiron [(F6H8) in people with Retinal Detachment, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of the study is to compare the safety, intraocular adverse effects and the anatomic and functional outcome with two endotamponade silicone oil after a 3-month in complex inferior retinal re-detachments. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Retinal Detachment
What is being tested?
Oxane HD [oil-RMN3-mixture] and Densiron [(F6H8)
How many people
0 participants
Where
1 siteMexico
Study dates
Aug 2006to Aug 2007
Phase
Phase 2/3
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients complicated persistent retinal detachment due secondary to proliferative vitreoretinopathy

Who cannot join

  • Diabetes
  • Uveitis
  • Glaucoma

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Asociacion Para Evitar la Ceguera en Mexico

    México, D.F, 04330

Other trials in Mexico

About this study

Official title: Comparison of Two High-Density Silicone Oils in Complicated Rhegmatogenous Retinal Detachment

The purpose of the study is to compare the safety, intraocular adverse effects and the anatomic and functional outcome with two endotamponade silicone oil after a 3-month in complex inferior retinal re-detachments.

Read the detailed description

Five to 10% of retinal detachments progressed to proliferative vitreoretinopathy (PVR), the common more cause of surgical failure of retina detachment.

Despite the use of internal tamponades, the treatment of retinal detachments due to a progressed proliferative vitreoretinopathy (PVR) is still a problem. At present, conventional silicone oil, having a lower specific gravity than water, is an excellent tool in advanced PVR retinal detachment especially of the upper circumference.

In the past, to diminish the re-detachments diverse heavier-than-water density endotamponades were investigated by to use in in cases of inferior PVR. However,heavier-than-water density endotamponades have demonstrated adverse short term effects. (Example: silicon dispersion: hypotension and inflammation)

Recently, two new long-term heavier-than-water internal tamponades were introduced: Oxane HD [oil-RMN3-mixture] and Densiron [mixture of 30.5 vol% perfluorohexyloctane (F6H8) with 69.5 vol% polydimethylsiloxane (silicone oil)], showing satisfying anatomical results and good intraocular tolerance.

In the present study, we will compare the anatomical outcome, functional results and intraocular adverse effects of two types of heavier tamponades.

Being tested
Oxane HD [oil-RMN3-mixture], Densiron [(F6H8)
Keywords
Retinal detachment, proliferative vitreoretinopathy, heavier-than-water internal tamponades
Medical subject headings
Retinal Detachment, Vitreoretinopathy, Proliferative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oxane HD [oil-RMN3-mixture]Drug

  • Densiron [(F6H8)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. visual acuity

  2. anatomical results

Secondary outcomes (9)

  1. complication: hypotony,

  2. vitreous hemorrhage,

  3. inflammatory reaction,

  4. cataract,

  5. chronic hypotony,

  6. IOP elevated intraocular pressure,

  7. pseudohypopyon,

  8. fibrin,

  9. emulsification droplets in the anterior chamber

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2006 (estimated)
  2. Study startAug 2006
  3. Primary completionAug 2006
  4. Study completionAug 2007

Why it stopped: Poor accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00403702
Sponsor's protocol ID
APEC-0021
Status last verified
May 2024
First submitted
2 Nov 2006
Last updated
3 Jun 2024
Results posted
No

Publications

  • Sandner D, Engelmann K. First experiences with high-density silicone oil (Densiron) as an intraocular tamponade in complex retinal detachment. Graefes Arch Clin Exp Ophthalmol. 2006 May;244(5):609-19. doi: 10.1007/s00417-005-0110-8. Epub 2005 Oct 5.

    PubMed 16205937

  • Theelen T, Tilanus MA, Klevering BJ. Intraocular inflammation following endotamponade with high-density silicone oil. Graefes Arch Clin Exp Ophthalmol. 2004 Jul;242(7):617-20. doi: 10.1007/s00417-004-0898-7. Epub 2004 Mar 17.

    PubMed 15029505

  • Nicolai U, Eckardt C, Kohlhoff M, Wottge HU. Biocompatibility of silicone oil and high-density liquids. An immunologic study. Ger J Ophthalmol. 1992;1(3-4):180-7.

    PubMed 1483133

  • Mester U, Rothe R, Zubcov A. Experimental studies with a high-density silicone oil for giant retinal tear. Ophthalmic Res. 1986;18(2):81-6. doi: 10.1159/000265419.

    PubMed 3737116

  • Wong D, Cazabon S, Ali H, Kumar I, Valldeperas X, Groenewald C, Pearce I. Can the sequential use of conventional silicone oil and heavy oil be a strategy for the management of proliferative vitreoretinopathy? Ann Acad Med Singap. 2006 Mar;35(3):181-4.

    PubMed 16625267

  • Scheer S, Boni S, Barale PO, Bourhis A, Bonnel S, Tuil E, Girmens JF, Buil O, Baudouin C, Laroche L, Nordmann JP, Poisson F, Warnet JM, Sahel JA. [Heavy silicone oil as internal tamponade for retinal detachment: efficacy and tolerance]. J Fr Ophtalmol. 2006 Feb;29(2):129-35. doi: 10.1016/s0181-5512(06)73760-3. French.

    PubMed 16523153

  • Tognetto D, Minutola D, Sanguinetti G, Ravalico G. Anatomical and functional outcomes after heavy silicone oil tamponade in vitreoretinal surgery for complicated retinal detachment: a pilot study. Ophthalmology. 2005 Sep;112(9):1574. doi: 10.1016/j.ophtha.2005.04.013.

    PubMed 16139666

  • Bhisitkul RB, Gonzalez VH. "Heavy oil" for intraocular tamponade in retinal detachment surgery. Br J Ophthalmol. 2005 Jun;89(6):649-50. doi: 10.1136/bjo.2004.057182. No abstract available.

    PubMed 15923493

  • Wolf S, Schon V, Meier P, Wiedemann P. Silicone oil-RMN3 mixture ("heavy silicone oil") as internal tamponade for complicated retinal detachment. Retina. 2003 Jun;23(3):335-42. doi: 10.1097/00006982-200306000-00008.

    PubMed 12824833

  • Rizzo S, Genovesi-Ebert F, Belting C, Vento A, Cresti F. A pilot study on the use of silicone oil-RMN3 as heavier-than-water endotamponade agent. Graefes Arch Clin Exp Ophthalmol. 2005 Nov;243(11):1153-7. doi: 10.1007/s00417-005-0015-6. Epub 2005 Jun 28.

    PubMed 15983817

  • Schwartz SG, Flynn HW Jr, Wang X, Kuriyan AE, Abariga SA, Lee WH. Tamponade in surgery for retinal detachment associated with proliferative vitreoretinopathy. Cochrane Database Syst Rev. 2020 May 13;5(5):CD006126. doi: 10.1002/14651858.CD006126.pub4.

    PubMed 32408387

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Oxane HD [oil-RMN3-mixture] and Densiron [(F6H8) in people with Retinal Detachment, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.

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 3 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: withdrawn, as of the sponsor's last update on 3 Jun 2024. 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 Mexico. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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.

What does the primary outcome measure?

visual acuity. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00403702, which also lists 11 linked publications.

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 3 Jun 2024.

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