Management protocol Prospectivestudyto evaluate the results of



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Prospective eye injury study Management protocol

Management protocol

Prospectivestudyto evaluate the results of

prophylactic chorioretinectomy

in eyes seriously injured eyes at high risk for

proliferative vitreoretinopathy (PVR)
General description

The goal of the study is to evaluate a new treatment method (prophylactic chorioretinectomy) for the treatment of eyes at high risk for PVR following severe trauma. These injuries have a poor anatomical and functional outcome once PVR has started. In this prospective study we intend to compare the results achieved with this proactive method to those published in the literature using traditional methods of treatment. The goal is to perform prophylactic chorioretinectomy within the first 100 after the injury.


Injury types included (see BETT for definitions)

• perforatinginjuriesentrance + exitwound;

• intraoular foreign body (IOFB)injury with a deep impact (involving the choroid choroid andpossibly the sclera;

• rupturesor penetrating wounds extendingposteriortoextraocular muscleinsertion.


Cases to be excluded

Infection (endophthalmitis) at any time during the treatment/follow-up period.



Endpoints


Primary: Occurrence of proliferation (proliferation occurring at any point during the follow-up period):

• PVR;


• full- or partial thickness retinal folds.

A distinction is to be made whether the PVR originates at where prophylactic chorioretinectomy has been performed or elsewhere in the eye.



Secondary

• Anatomical failure (enucleation, evisceration, phthisis);

• visualacuity;

• lensstatus;

• retinalattachment;

• siliconeoilineye;

• intraocularpressure (IOP).
Management protocol

The intended plan is either to perform

1) primary surgery as soon as possible; this is followed by postoperative care and then secondary vitrectomy with prophylactic chorioretinectomy, preferably no later than 100 hours postinjury or

2) primary comprehensive surgery (wound closure + vitrectomy with prophylactic chorioretinectomy.

(It is conceivable that no primary surgery is necessary - e.g., the wound is too small to require closure and no anterior segment pathology requiring surgical intervention is present -; strictly speaking, in such cases the secondary surgery is the primary surgery, but for data entry and analysis purposes, such intervention remains to be called secondary surgery. It is also possible that the second surgery is performed >100 hours after the injury. Although it is not preferable, this does NOT disqualify the case, just indicate this fact on the sheet.)
Primary (emergency) surgery

• closewound(if it can reasonablybereached) as soon as possible;

• clearanterioropacity(hyphema, cataract etc.) asnecessarysurgeon’s decision;

• in eyes with a perforating injury, it is preferred although not mandatory to perform limited indirect ophthalmoscopic vitrectomy withwithout anteriorchamber infusion tocut intravitrealtractionpathway; no indirect ophthalmoscopic vitrectomy in the other two injury types;

• in eyes with an IOFB, it is the surgeon’s decision whether the IOFB is removed now delayed until the secondary surgery

• do not use scleral buckle.



If patient is referred with the primary surgery already performed elsewhere, skip to “postoperative case” section.
Postoperative care

• heavytopicalsteroids (systemiccorticosteroids: surgeon’s decision);

• other topical/systemic medications as needed surgeon’s decision;

• intravenous/intravitreal antibiotics:surgeon’s decision.


Secondarysurgery,whether followingown primary surgeryorreferral

Must be performed no later than 100 hours postinjury.

Pars plana vitrectomy: complete removal of all vitreous, including posterior cortical vitreous and vitreous base:

• use triamcinolone to stain posterior cortical vitreous;

• use scleral indentation to assure complete removal of peripheral vitreous;

remove lens, even if clear, if this is felt necessary to get access to vitreous base;

• pay close attention to cut/remove incarcerated vitreous around wounds/IOFB impact site;

• removal of the IOFB if still present.

Judicious retinectomyaroundretinal incarceration into exit/rupture wound orIOFB impactsite:

• deepdiathermy (involving choroid, not just retina; use the highest power of the diathermy machine);

• destroy retina and choroid so that a 1 mm “ring” of bare sclera around the incarceration site remains;

• if wound is too close to fovea, appropriately reduce the width of the ring juxtafoveally but keep it 1 mm elsewhere;

• no need to trim proliferative tissue plugging the exit/rupture wound;

• use forceps to gently lift remaining retina, verifying that remaining retinal edge is free of any tissue connection;

• perform lasercerclagearoundretinectomyandinperiphery;

• use siliconeoilorgas for tamponade;

• inject 4 mgtriamcinolone/400µg dexamethasone intravitreallyat the endofsurgery, unless contraidicated (glaucoma).

• Do not use scleral buckle.

• Iflenswasremovedit is the surgeon’sdecision whether the posterior capsule is also removed, although this is preferred.

IOL implantation:surgeon’sdecision; delayed implantation is preferred.
Postoperative care

• heavytopicalsteroids; systemiccorticosteroids: surgeon’s decision;

• other topical/systemic medications as needed surgeon’s decision;

• intravenous/intravitreal antibiotics:surgeon’s decision.


Primary comprehensive surgery

All elements/steps described above apply, but all done in a single surgical setting.



Follow-up

Length: Minimalfollowupof6months,whetherornotoilremoved. Oneyearfollowuppreferred.

Visits schedule: Surgeon’sdecision; visits at 1 month and 3 months post secondary surgery preferred.




Documentation


• Videotapeofthesurgeries requested.

• Copy of surgery description requested, with schematic drawing of wound/s.

• Photographsof posterior pole at all postoperative visit requested.

• MacularOCT at final visit (6 months) requested.



Data entry to database

• fill out initial report form no later than 1 week after injury;

• submit interim and final reports within 2 weeks after then examination.

All requested details must be reported on.



Literature to use if necessary
Kuhn, F., Teixeira, S., Pelayes, D. Late versus prophylactic chorioretinectomy for the prevention of trauma-related proliferative chorioretinectomy.

Ophthalmic Research 48 S1:331-37, 2012
Kuhn, F., Mester, V., Morris, R. A proactive treatment approach for eyes with perforating injury.

Klinische Monatsblatter für Augenheilkunde 221: 622-628, 2004


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