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Steroid During Surgery vs Eye Drops After Surgery for Retinal Detachment (DVS Trial)
Phase 4
Recruiting
Led By Nimesh A. Patel, MD
Research Sponsored by Massachusetts Eye and Ear Infirmary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Primary rhegmatogenous retinal detachment (mac-on or mac-off) requiring pars plana vitrectomy (23, 25 and 27-gauge)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, 7, 30 and 90 after surgical procedure
Awards & highlights
DVS Trial Summary
This trial showed that using a steroid at the time of surgery was just as effective as using eye drops afterwards for people who had surgery to repair a detached retina.
Who is the study for?
This trial is for individuals with a primary type of retinal detachment who need surgery and can start treatment within seven days of diagnosis. It's not for those with prior eye surgeries (except laser), glaucoma, giant tears, or certain eye conditions like infections or inflammations.Check my eligibility
What is being tested?
The study tests if using triamcinolone acetonide during surgery is as good as post-surgery eye drops in treating retinal detachment. Patients won't use post-op drops but will receive other standard medications and undergo pars plana vitrectomy.See study design
What are the potential side effects?
Possible side effects include increased pressure inside the eye, allergic reactions to the drugs used, temporary vision changes, discomfort or redness in the eye area, and a risk of infection.
DVS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need surgery for a specific type of retinal detachment.
DVS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1, 7, 30 and 90 after surgical procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, 7, 30 and 90 after surgical procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Adverse events
Degree of pain
Intraocular pressure less than 5 or more 30 mmHg
+7 moreDVS Trial Design
2Treatment groups
Active Control
Group I: Group 2Active Control2 Interventions
Subtenon triamcinolone acetonide (40 mg/1mLl) at the time of surgery
Subconjunctival antibiotic (cefazolin 50 mg/0.5 mL, moxifloxacin 0.5 mg/0.1 mL, or vancomycin 1 mg/0.1 mL) and subconjunctival dexamethasone (4 mg/mL) at the time of surgery
Topical atropine 1% and antibiotic-steroid ointment (neomycin-polymyxin B-dexamethasone) at the time of surgery
No postoperative eye drops
Group II: Group 1Active Control4 Interventions
Subconjunctival antibiotic (cefazolin 50 mg/0.5 mL, moxifloxacin 0.5 mg/0.1 mL, or vancomycin 1 mg/0.1 mL) and subconjunctival dexamethasone (4 mg/mL) at the time of surgery
Topical atropine 1% and antibiotic-steroid ointment (neomycin-polymyxin B-dexamethasone) at the time of surgery
Topical moxifloxacin 0.5% or Polymyxin/Trimethoprim if patient is allergic to moxifloxacin; 4 times per day for 1 week after surgery.
Topical prednisolone 1% 1 drop 4 times per day tapered by one drop weekly for 4 weeks (4/3/2/1 taper)
Topical atropine 1% daily for 1 week
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Who is running the clinical trial?
Massachusetts Eye and Ear InfirmaryLead Sponsor
106 Previous Clinical Trials
12,781 Total Patients Enrolled
1 Trials studying Retinal Detachment
48 Patients Enrolled for Retinal Detachment
Nimesh A. Patel, MDPrincipal InvestigatorMassachusetts Eye and Ear
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need surgery for a specific type of retinal detachment.I have been diagnosed with an advanced stage of diabetic eye disease.I am unable to make decisions for myself.I cannot use or apply eye drops.I do not speak English.I had laser eye surgery in the past month.You have known or suspected allergies to any of the medications used during or after the surgery.You need silicone oil to help with a medical procedure.I have inflammation in the front part of my eye.I have had a retinal detachment in the eye that will be operated on.I have glaucoma or my eye pressure is above 21 mmHg.I have responded well to steroid treatments in the past.I am currently using corticosteroids in a pill, cream, or eye injection form.I have had eye surgery before, but not laser surgery.My eye surgery was scheduled more than a week after my diagnosis.I have been diagnosed with a complex retinal disease.I have or had chronic eye inflammation.I have signs of an eye infection.I need surgery for cataract or lens removal.I was diagnosed with a giant tear in my retina.I have not had eye surgery (except laser) in the last 6 months.I have an active eye infection.I do not have any uncontrolled eye or systemic diseases.I haven't had an eye injection in the last month.
Research Study Groups:
This trial has the following groups:- Group 1: Group 2
- Group 2: Group 1
Awards:
This trial has 5 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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.
What is the participant capacity of this trial?
"Affirmative. The clinical trial is still recruiting, as indicated on the clinicaltrials.gov website. This experiment initially launched on July 25th 2022 and was last modified a day later; 168 participants are required from one site to complete it successfully."
Answered by AI
To what degree can Group 1 present a hazard to humans?
"The risk associated with Group 1 is low, thus it has been assigned a score of 3. This assessment was made based on the fact that this trial is in Phase 4, and therefore such treatment has already been approved by relevant authorities."
Answered by AI
Are there any vacant opportunities for individuals to participate in this clinical experiment?
"Affirmative. The clinical trial registry on clinicaltrials.gov reveals that this research project, which was first put up on July 25th 2022, is actively enrolling patients. 168 participants need to be recruited from 1 location."
Answered by AI
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