Steroid During Surgery vs Eye Drops After Surgery for Retinal Detachment

(DVS Trial)

Overseen By Sandra Alhoyek, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Massachusetts Eye and Ear Infirmary

Must not be taking: Corticosteroids

Disqualifiers: Glaucoma, Diabetic retinopathy, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

168 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a steroid injection during surgery is as effective as using eye drops after surgery for individuals with retinal detachment. Retinal detachment occurs when the retina, a layer at the back of the eye, peels away, potentially causing vision loss if untreated. The study compares two groups: one receiving steroids directly during surgery and the other using eye drops afterward. Individuals with a specific type of retinal detachment who require a surgery called pars plana vitrectomy (a procedure to remove the vitreous gel from the eye) might be suitable candidates. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those currently using oral, topical, or intravitreal corticosteroids. If you are on these medications, you may not be eligible to participate.

What is the safety track record for these treatments?

Research has shown that triamcinolone acetonide is generally safe for use in eye surgeries. One study found it improves surgery outcomes and reduces risks such as increased eye pressure afterward. Another study reported no serious side effects when used in eye surgery.

For prednisolone, studies suggest it effectively reduces inflammation and pain after eye surgery. It is commonly used to manage inflammation post-surgery, and no major safety concerns have been reported in eye treatments.

Both treatments have a strong safety record in eye surgeries, with few adverse events reported. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for retinal detachment surgery because they explore different approaches to managing inflammation and infection. One group receives a steroid, Triamcinolone Acetonide, directly during surgery, potentially reducing the need for postoperative eye drops. This direct delivery method could provide immediate anti-inflammatory effects, which might prevent complications more effectively than standard postoperative drops. On the other hand, the second group continues with the traditional approach of using eye drops after surgery, but with a structured tapering schedule for steroids. This trial could help determine if intraoperative steroids are more efficient and convenient than the current post-surgery eye drop regimen.

What evidence suggests that this trial's treatments could be effective for retinal detachment?

In this trial, participants will join one of two groups. Group 2 will receive triamcinolone acetonide during surgery. Earlier research using triamcinolone acetonide during surgery showed promising results, with about 94% of patients experiencing improved vision over time. Another study found that the retina was successfully reattached in all cases, with no signs of damage.

Group 1 will receive prednisolone eye drops after surgery. Prednisolone eye drops have reduced fluid in the retina but have shown mixed results for vision improvement. Some studies found no significant difference in vision improvement compared to other treatments.

Overall, using triamcinolone during surgery has consistently produced positive results for better vision and successful retinal reattachment. ^{1 6 7 8 9}

Who Is on the Research Team?

Nimesh A Patel, MD

Principal Investigator

Massachusetts Eye and Ear

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I need surgery for a specific type of retinal detachment.

Exclusion Criteria

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo pars plana vitrectomy with either subtenon triamcinolone acetonide or postoperative eye drops

1 day

1 visit (in-person)

Postoperative Treatment

Participants receive postoperative care including antibiotics and corticosteroids, with Group 1 receiving eye drops and Group 2 receiving subtenon injection

4 weeks

Multiple visits (in-person) for follow-up assessments

Follow-up

Participants are monitored for safety and effectiveness, including assessments of visual acuity, intraocular pressure, and adverse events

12 weeks

Visits on Day 1, 7, 30, and 90 after surgery

What Are the Treatments Tested in This Trial?

Interventions

• Atropine 1%
• Moxifloxacin 0.5% or Polymyxin/Trimethoprim if patient is allergic to moxifloxacin
• Pars plana vitrectomy
• Prednisolone 1%
• Triamcinolone Acetonide 40mg/mL

Trial Overview 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.

How Is the Trial Designed?

Group I: Group 2 Active Control 2 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 1 Active Control 4 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

Pars plana vitrectomy is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Hycamtin for:

• Ovarian cancer
• Small cell lung cancer
• Cervical cancer

Approved in United States as Hycamtin for:

• Ovarian cancer
• Small cell lung cancer
• Cervical cancer

Approved in Canada as Hycamtin for:

• Ovarian cancer
• Small cell lung cancer
• Cervical cancer

Who Is Running the Clinical Trial?

Massachusetts Eye and Ear Infirmary

Lead Sponsor

Trials

115

Recruited

15,000+

Published Research Related to This Trial

A single posterior subtenon injection of triamcinolone acetonide (TA) is as effective as a 4-week course of prednisolone acetate 1% eyedrops in reducing intraocular inflammation after pars plana vitrectomy (PPV), based on a study of 40 patients.

Both treatment methods showed similar safety profiles, with no significant differences in pain, inflammation, or side effects, and no cases of steroid-induced intraocular hypertension were reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-inflammatory efficacy of a single posterior subtenon injection of triamcinolone acetonide versus prednisolone acetate 1% eyedrops after pars plana vitrectomy. Paccola, L., Jorge, R., Barbosa, JC., et al.[2014]

In a pilot study of 24 patients with complex retinal detachment and extreme proliferative vitreoretinopathy, the application of Triamcinolone Acetonide (TA) crystal drops under silicone oil after surgery led to significantly better visual recovery compared to the control group without TA.

The use of TA crystals also resulted in fewer recurrences of retinal detachment and a higher rate of successful silicone oil removal, indicating improved anatomical outcomes and reduced complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complete manuscript title: role of sub-silicone oil application of triamcinolone acetonide (TA) drops on outcomes after 360° relaxing retinectomy: a pilot study. Boral, SK., Agarwal, D., Das, A., et al.[2023]

In a case series of three patients undergoing TA-assisted vitrectomy for retinal detachment, subretinal deposition of triamcinolone acetonide (TA) was observed but resolved completely within three weeks without causing any adverse effects.

The successful attachment of the retina was confirmed two months post-surgery, suggesting that the presence of TA granules does not lead to functional damage, indicating that surgical removal of these deposits may not be necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Natural history of sub-retinal triamcinolone acetonide deposition after triamcinolone-assisted vitrectomy. Sampangi, R., Venkatesh, P., Garg, SP.[2018]

In a phase III study involving 60 patients undergoing pars plana vitrectomy, preservative-free triamcinolone significantly improved visualization of posterior segment structures, with mean scores increasing from 0.5 to 3.7 after instillation (P < 0.0001).

Over 90% of surgeons reported that preservative-free triamcinolone enhanced visualization, and no safety issues were identified, indicating it is a safe and effective option for improving surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of the safety and efficacy of preservative-free triamcinolone (triesence [triamcinolone acetonide injectable suspension] 40 mg/ml) for visualization during pars plana vitrectomy. Dyer, D., Callanan, D., Bochow, T., et al.[2015]

In a study of 75 patients undergoing vitrectomy for idiopathic epiretinal membrane, the use of triamcinolone acetonide (TA) as an adjuvant therapy led to a significant reduction in central macular thickness compared to those who did not receive TA.

While both groups showed improvement in visual acuity after surgery, there was no significant difference in visual acuity change between the TA group and the control group, indicating that while TA may enhance anatomical outcomes, it does not necessarily translate to better functional outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Concomitant Triamcinolone Acetonide Injection in Small-Gauge Vitrectomy for Idiopathic Epiretinal Membrane Peel. Sella, R., Gal-or, O., Goh, YW., et al.[2017]

In a study of 45 patients undergoing pars plana vitrectomy (PPV), the use of triamcinolone acetonide (TA) significantly reduced postoperative inflammation, as indicated by lower Tyndallometric mean values compared to a control group without TA.

Patients treated with TA showed improved recovery dynamics, with lower levels of blood-aqueous barrier disruption measured at 1 day, 10 days, and 6 weeks post-surgery, suggesting that TA administration enhances postoperative outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Decrease of the postoperative inflammatory reaction during pars plana vitrectomy (PPV) after administration of triamcinolone acetonide]. Mańkowska, A., Rejdak, R., Oleszczuk, A., et al.[2013]

Intraoperative use of triamcinolone acetonide (TA) during pars plana vitrectomy (PPV) significantly reduced the incidence of retinal breaks (8.7% vs. 14.1%) and retinal detachments (0.8% vs. 3.7%) compared to conventional PPV, based on a study of 774 patients across 8 hospitals.

While patients in the TA-assisted group required more antiglaucoma eye drops postoperatively, there were no serious adverse events related to TA use, indicating it is a safe option that enhances surgical outcomes without increasing major risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced incidence of intraoperative complications in a multicenter controlled clinical trial of triamcinolone in vitrectomy. Yamakiri, K., Sakamoto, T., Noda, Y., et al.[2015]

Injected triamcinolone acetonide (TA) does not mix well with silicone oil and can form harmful crystals that may damage retinal cells, highlighting a potential safety concern in its use during surgery.

Creating a suspension of TA in silicone oil before injection allows for a stable, noncytotoxic release of TA over 90 days, suggesting a safer and more effective method for delivering this treatment in surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The distribution, release kinetics, and biocompatibility of triamcinolone injected and dispersed in silicone oil. Spitzer, MS., Kaczmarek, RT., Yoeruek, E., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7187156/

Local delivery of corticosteroids in clinical ophthalmology A study on corneal inflammation demonstrated greater anti‐inflammatory effects when topical prednisolone acetate is applied every 15 minutes (or five doses at 1 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11280446/

PREDNISOLONE EYE DROPS AS A POTENTIAL ... Topical treatment with prednisolone eye drops resulted in a reduction of retinal fluid in all cases, although improvement in visual acuity (VA) was inconsistent ...

3. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-effects-of-prednisolone-acetate-and-placebo-eye-drops-for-patients-with-chronic-central-serous-chorioretinopathy/

Study on the Effects of Prednisolone Acetate and Placebo ... The trial will compare the effects of Pred Forte eye drops with a placebo to see how they affect fluid buildup in the eye, which is a common issue in cCSC.

4. jamanetwork.com jamanetwork.com/journals/jamaophthalmology/fullarticle/2782731

Prednisolone and Ketorolac vs Ketorolac Monotherapy or ... Findings In this randomized clinical trial with 470 participants, no differences in central subfield thickness or visual acuity across treatment ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/aos.14018

Preoperative anti‐inflammatory treatment of diabetic ... Purpose To examine preoperative anti-inflammatory treatment on recovery from cataract surgery in eyes of diabetic patients.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/19924670/

Effect of oral prednisolone on visual outcomes and ... Conclusions: Postoperative oral prednisolone does not seem to improve the visual outcomes and complications of scleral buckling in simple phakic RRD.

7. retinatoday.com retinatoday.com/articles/2010-nov-dec-supplement/topical-steroids-for-therapeutic-use-in-the-posterior-segment

Topical Steroids for Therapeutic Use in the Posterior ... Patients with DME and PVR or with dislocated lenses and significant anterior and posterior segment inflammation may benefit from a potent topical steroid.

8. crstoday.com crstoday.com/articles/2010-apr/the-next-generation-steroid

The Next-Generation Steroid The goal was to assess the efficacy and safety of Durezol dosed b.i.d. and q.i.d., beginning 1 day after intraocular surgery, in eyes with more than 10 anterior ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT05620901

DEXTENZA in Pediatric Patients Following Retinal Surgery ... Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QUID) ...