retinal detachment and the development of scarring (proliferative vitreoretinopathy) in patients with open globe trauma MedDRA version: 17.0 Level: LLT Classification code 10057896 Term: Proliferative vitreoretinopathy System Organ Class: 10015919 - Eye disorders MedDRA version: 17.0 Level: PT Classification code 10038848 Term: Retinal detachment System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: Kenalog
Product Name: Kenalog
Pharmaceutical Form: Injection
INN or Proposed INN: Triamcinolone Acetonide
CAS Number: 76-25-5
Concentration unit: mg/ml milligram(s)/millilitre
Concentratio
Sponsors
Moorfields Eye Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult subjects (Aged 18 years or over at the time of enrolment) 2. Full thickness, open-globe ocular trauma undergoing vitrectomy 3. Ability to give written informed consent 4. Willingness to accept randomization and attend follow-up for 6 months. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1. Children (Age less than 18 years old at time of enrollment) 2. Pre-existing uncontrolled uveitis (This does not include patients whose uveitis is secondary to their injury or retinal detachment) 3. Definitive diagnosis of previous steroid induced glaucoma – (this does not include patients in whom a query of previous steroid-induced raised IOP has been postulated) 4. Pregnant or Breastfeeding females (Females of childbearing potential must be willing to use an effective method of contraception (hormonal or barrier method of birth control; true abstinence) from the time consent is signed until 6 weeks after completion of the trial. Females of childbearing potential must have a negative urinary pregnancy test within 7 days prior to being registered for trial treatment (Subjects are considered not of child bearing potential if they are permanently sterile (i.e. they have undergone a hysterectomy, bilateral tubal occlusion, or bilateral salpingectomy) or they are postmenopausal). 5. Allergy or previous known adverse reaction to triamcinolone acetonide 6. Inability to attend regular follow up. 7. Unable to give written informed consent. 8. Current or planned systemic corticosteroid use of a dose above physiological levels (e.g. >10mg prednisolone)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In patients who have sustained an open globe injury (severe trauma) and are undergoing vitrectomy surgery as a result(procedure to clear the gel in the back of the eye) , does the use of a steroid injection into and around the eye improve the visual outcome at 6 months?;Secondary Objective: In patients who have sustained an open globe injury (severe trauma) and are undergoing vitrectomy surgery as a result(procedure to clear the gel in the back of the eye) , does the use of a steroid injection into and around the eye (a) reduce the proportion of patients in whom retinal detachment with scarring occurs at any timepoint within 6 months of the study surgery (b) increase the proportion of patients in whom stable complete retinal reattachment is achieved at 6 months post study surgery (c) increase the proportion of patients in whom stable central retinal reattachmen is achieved at 6 months post study surgery (d) decrease the proportion of patients in whom a tractional retinal detachment (no retinal hole) occurs at any timepoint within 6 months of the study surgery (e) reduce the number of operations required to achieve stable retinal reattachment (either complete or central) at 6 months after the study surgery (f) reduce the proportion of patients who suffer hypoton;Primary end point(s): Dual primary outcome 1) Corrected visual acuity score (ETDRS letter score) at 6 months after initial study surgery 2) Proportion of patients with an improvement from baseline to 6 months of at least 10 on the corrected visual acuity (ETDRS letter score) ;Timepoint(s) of evaluation of this end point: Time-points of evaluation will be undertaken at baseline (prior to initial study surgery), three months after initial surgery and six months after initial surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To determine whether adjunctive intraocular and periocular steroid (triamcinolone acetonide) influences the development of scarring (proliferative vitreoretinopathy), retinal detachment, intraocular pressure abnormalities and other complications in eyes undergoing surgery for open globe trauma. In addition to assess the effects of treatment on quality of life measured using the EQ-5D, VFQ25 tools;Timepoint(s) of evaluation of this end point: Time-points of evaluation will be undertaken at baseline (prior to initial study surgery), three months after initial surgery and six months after initial surgery. | — |
Countries
United Kingdom
Contacts
Public ContactNatasha Ajraam
Moorfields Eye Hospital NHS Foundation Trust
Outcome results
None listed