NCT00403702

Brief 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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2006

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 27, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

June 3, 2024

Status Verified

May 1, 2024

Enrollment Period

Same day

First QC Date

November 2, 2006

Last Update Submit

May 31, 2024

Conditions

Retinal Detachment

Keywords

Retinal detachmentproliferative vitreoretinopathyheavier-than-water internal tamponades

Outcome Measures

Primary Outcomes (2)

  • visual acuity

  • anatomical results

Secondary Outcomes (9)

  • complication: hypotony,

  • vitreous hemorrhage,

  • inflammatory reaction,

  • cataract,

  • chronic hypotony,

  • +4 more secondary outcomes

Interventions

Oxane HD [oil-RMN3-mixture]DRUG
Densiron [(F6H8)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients complicated persistent retinal detachment due secondary to proliferative vitreoretinopathy

You may not qualify if:

  • Diabetes
  • Uveitis
  • Glaucoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asociacion Para Evitar la Ceguera en Mexico

México, D.F, 04330, Mexico

Location

Related Publications (11)

  • 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.

    PMID: 16205937BACKGROUND

  • 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.

    PMID: 15029505BACKGROUND

  • 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.

    PMID: 1483133BACKGROUND

  • 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.

    PMID: 3737116BACKGROUND

  • 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.

    PMID: 16625267BACKGROUND

  • 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.

    PMID: 16523153BACKGROUND

  • 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.

    PMID: 16139666BACKGROUND

  • 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.

    PMID: 15923493BACKGROUND

  • 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.

    PMID: 12824833BACKGROUND

  • 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.

    PMID: 15983817BACKGROUND

  • 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.

    PMID: 32408387DERIVED

MeSH Terms

Conditions

Retinal DetachmentVitreoretinopathy, Proliferative

Interventions

oxane HDdensiron

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Hugo Quiroz-Mercado, MD

    Asociación para Evitar la Ceguera en México

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 2, 2006

First Posted

November 27, 2006

Study Start

August 1, 2006

Primary Completion

August 1, 2006

Study Completion

August 1, 2007

Last Updated

June 3, 2024

Record last verified: 2024-05

Locations

ME(1)