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Head Positioning for Retinal Detachment (DIAMOND Trial)
N/A
Recruiting
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18
Diagnosis of primary rhegmatogenous retinal detachment needing pars plana vitrectomy with the detachment involving at least one of the temporal vascular arcades, which would allow retinal displacement to be detected on fundus autofluorescence photography
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
DIAMOND Trial Summary
This trial found that patients who had their retina reattached with surgery and were positioned facedown or according to the retinal break immediately postoperatively were less likely to experience image distortion than those who were positioned supine.
Who is the study for?
This trial is for adults over 18 with a specific type of eye problem called primary rhegmatogenous retinal detachment, where the retina has come loose in a certain area. They must be able to have their eyes photographed after surgery and keep their head in a set position afterwards. People can't join if they've had certain severe eye conditions, previous similar surgeries, mental incapacity, or can't hold their head still post-surgery.Check my eligibility
What is being tested?
The study is testing two different ways of positioning patients' heads after eye surgery for retinal detachment: lying on the back (supine) or facing down. The goal is to see which method better prevents the retina from moving out of place by comparing images taken before and after surgery.See study design
What are the potential side effects?
There are no direct side effects mentioned from the head positioning interventions themselves; however, general risks associated with vitrectomy may include infection, bleeding inside the eye, increased pressure within the eye, cataracts or vision loss.
DIAMOND Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have a specific type of retinal detachment and need surgery.
DIAMOND Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Retinal displacement
Secondary outcome measures
Aniseikonia
Best corrected Visual Acuity measured in "Early Treatment of Diabetic Retinopathy Study" letters
Metamorphopsia
+3 moreDIAMOND Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Supine positioningExperimental Treatment1 Intervention
Patients in the second arm will be kept supine after the completion of their surgery. They will then be taken to the recovery area where, once transferred to the care of the postoperative care unit staff, they will maintain supine positioning. They will maintain this positioning until their first day postoperative visit after which they will position according to the retinal breaks found during surgery.
Group II: Conventional face down positioningActive Control1 Intervention
Patients in third arm will be treated with the current standard of care, that is, they will be kept supine in the ophthalmic surgery chair after the completion of their surgery. They will then be taken to the recovery area where, once transferred to the care of the postoperative care unit staff, they will transition to face down positioning. They will maintain this positioning until their first day postoperative visit after which they will position according to the retinal breaks found during surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Supine positioning
2008
N/A
~120
Find a Location
Who is running the clinical trial?
Unity Health TorontoLead Sponsor
541 Previous Clinical Trials
447,516 Total Patients Enrolled
5 Trials studying Retinal Detachment
708 Patients Enrolled for Retinal Detachment
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am mentally capable of understanding and participating in the trial.I am 18 years old or older.My eye surgery used silicone oil, not gas.I cannot keep my head in the right position after surgery.I had surgery for a detached retina or need it after another procedure didn’t work.My retina is detached, but the central part is still attached.My eye condition is severe, with advanced retinopathy.I have experienced double vision with both eyes before surgery.I have a specific type of retinal detachment and need surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Conventional face down positioning
- Group 2: Supine positioning
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can people with the qualifying medical condition enroll in this trial now?
"Yes, this is an active trial recruiting 324 patients from 1 location. The listing on clinicaltrials.gov says that the trial was originally posted on 8/26/2019 and was most recently edited on 4/27/2021."
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