NCT02185469

Brief Summary

There are multiple ways to treat retinal detachment, the aim of this study is to compare the amount of corneal endothelial cell loss after pneumatic retinopexy in comparison to vitrectomy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

June 9, 2014

Completed
22 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 9, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 9, 2014

Status Verified

July 1, 2014

Enrollment Period

11 months

First QC Date

June 9, 2014

Last Update Submit

July 8, 2014

Conditions

Rhegmatogenous Retinal Detachment

Keywords

Corneal Endothelial Cell Losspneumatic retinopexyvitrectomy

Outcome Measures

Primary Outcomes (1)

  • Endothelial cells count as measured by specular microscopy

    at 3 and 6 months

Study Arms (2)

pneumatic retinopexy group

ACTIVE COMPARATOR

First, a 5/8-in 25-gauge needle will be used to perform an anterior chamber paracentesis, aiming to withdraw a minimum of 0.3 ml of aqueous fluid form the anterior chamber. Then, sulfur hexafluoride (SF6) will be injected in the vitreous cavity. The total volume of gas injected will exceed by 0.3 ml the amount of fluid withdrawn by the anterior chamber paracentesis (ex: 0.6 ml of SF6 would be injected after having withdrawn 0.3 ml). The laser retinopexy will be performed 48 hours later with laser.

Procedure: Pneumatic retinopexyDrug: sulfur hexafluoride (SF6)Device: 5/8-in 25-gauge needleDevice: laser

vitrectomy group

ACTIVE COMPARATOR

Under certain circumstances, pneumatic retinopexy can't be considered as a primary treatment for rhegmatogenous retinal detachment. In these cases, the patient will be booked for urgent 25 G vitrectomy with intraoperative laser retinopexy and gas injection to treat retinal detachment

Procedure: vitrectomyDevice: laser

Interventions

Pneumatic retinopexyPROCEDURE

First, a 5/8-in 25-gauge needle will be used to perform an anterior chamber paracentesis, aiming to withdraw a minimum of 0.3 ml of aqueous fluid form the anterior chamber. Then, sulfur hexafluoride (SF6) will be injected in the vitreous cavity. The total volume of gas injected will exceed by 0.3 ml the amount of fluid withdrawn by the anterior chamber paracentesis (ex: 0.6 ml of SF6 would be injected after having withdrawn 0.3 ml). The laser retinopexy will be performed 48 hours later with laser.

pneumatic retinopexy group
vitrectomyPROCEDURE

Under certain circumstances, pneumatic retinopexy can't be considered as a primary treatment for rhegmatogenous retinal detachment. In these cases, the patient will be booked for urgent 25 G vitrectomy with intraoperative laser retinopexy and gas injection to treat retinal detachment

vitrectomy group
sulfur hexafluoride (SF6)DRUG
pneumatic retinopexy group
5/8-in 25-gauge needleDEVICE
pneumatic retinopexy group
laserDEVICE

intraoperative laser retinopexy

pneumatic retinopexy groupvitrectomy group

Eligibility Criteria

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

You may qualify if:

  • Age more than 18 years old.
  • Patients with rhegmatogenous retinal detachment undergoing pneumatic retinopexy and pars plana vitrectomy.
  • Patients on which specular microscopy and IOLMaster® can be performed without delaying their treatment (availability of a qualified operator).
  • Decision makers able to give informed consent.

You may not qualify if:

  • Unable to attend follow-up visits.
  • History of previous intraocular surgery in surgical eye, except cataract extraction by phacoemulsification.
  • Aphakia in surgical eye.
  • Presence of an anterior chamber intraocular lens in surgical eye.
  • Need for cryotherapy to treat the retinal break.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Corneal Endothelial Cell Loss

Interventions

VitrectomySulfur HexafluorideLasers

Condition Hierarchy (Ancestors)

Corneal DiseasesEye DiseasesEye ManifestationsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, OperativeFluoridesHydrofluoric AcidFluorine CompoundsInorganic ChemicalsGasesSulfur CompoundsOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Peter Kertes, MD, CM, FRCSC

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlene Muller, RN, PHN,CCRP

CONTACT

416-480-5091charlene.muller@sunnybrook.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Peter Kertes ,MD, CM, FRCSC Chief of Ophthalmology, Retina Specialist

Study Record Dates

First Submitted

June 9, 2014

First Posted

July 9, 2014

Study Start

July 1, 2014

Primary Completion

June 1, 2015

Study Completion

July 1, 2015

Last Updated

July 9, 2014

Record last verified: 2014-07

Locations

CA(1)