Health TrialsbyHealthPanel

Dropless Pars Plana Vitrectomy Study

ConditionRhegmatogenous Retinal Detachment
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40+
SponsorMassachusetts Eye and Ear Infirmary

About this trial

To demonstrate that intraoperative use of subtenon triamcinolone acetonide at the time of surgery without postoperative eye drops is non-inferior to the regimen of postoperative eye drops following primary pars plana vitrectomy for retinal detachment.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Primary rhegmatogenous retinal detachment (mac-on or mac-off) requiring pars plana vitrectomy (23, 25 and 27-gauge)

Disqualifiers

Need for concomitant lensectomy or cataract surgery

Pars plana vitrectomy taking place more than seven days after the initial diagnosis

History of any prior vitreoretinal surgery (excluding laser surgery) in surgical eye

History of previous retinal detachment in surgical eye

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pars plana vitrectomy

    Procedure/Surgery

    Standard of care surgery

  • Triamcinolone Acetonide 40mg/mL

    Drug

    Sub-tenon injection of triamcinolone acetonide (40mg/mL) at the time of surgery

  • Moxifloxacin 0.5% or Polymyxin/Trimethoprim if patient is allergic to moxifloxacin

    Drug

    Antibiotic eye drop 4 times per day for 1 week after surgery

  • Prednisolone 1%

    Drug

    Steroid eye drop 4 times per day tapered by one drop weekly for 4 weeks (4/3/2/1 taper) after surgery

  • Atropine 1%

    Drug

    Eye drop daily for 1 week after surgery

Treatment groups

168 Participants
are divided into 2 treatment groups
Group A: Group 1Active comparator 4 interventions
Group B: Group 2Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Mean anterior chamber cell

Mean anterior chamber cell based on SUN (Standardization of Uveitis Nomenclature) criteria as measured by Slit Lamp Biomicroscopy

Time frame
Day 7 after surgical procedure

Secondary outcomes

1

Mean anterior chamber cell

Mean anterior chamber cell based on Standardization of Uveitis Nomenclature (SUN) criteria as measured by Slit Lamp Biomicroscopy

Time frame
Day 1, 30 and 90 after surgical procedure
2

Need for rescue medication (corticosteroid)

Need for additional medication (corticosteroid) to control post-operative inflammation

Time frame
Day 1, 7, 30 and 90 after surgical procedure
3

Intraocular pressure less than 5 or more 30 mmHg

Intraocular pressure measured by applanation tonometer or tono-pen

Time frame
Day 1, 7, 30 and 90 after surgical procedure
4

Need for medications to reduce intraocular pressure

Need for additional medication to reduce intraocular pressure

Time frame
Day 1, 7, 30 and 90 after surgical procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts Eye and Ear Infirmary

Lead sponsor

Source ClinicalTrials.gov
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