The Genesis of a Glaucoma Therapy
ECP's inventor talks about the history and development of the technology.
AN
INTERVIEW WITH MARTIN URAM, M.D.
ILLUSTRATION: COURTESY OF ENDO OPTIKS
An ECP laser can be
precisely applied and its intensity controlled, so a safe and effective procedure has evolved. |
Ophthalmology Management sat down with Martin Uram, M.D., cofounder and chairman of New Jersey-based Endo Optiks and creator of the Endoscopic CycloPhotocoagulation (ECP) procedure to discuss his inspiration for developing ECP, describe the technique and how it can help glaucoma patients with cataracts.
Q. Could you briefly describe what ECP is? Combining an endoscope for imaging and illumination with a laser in a single 20-gauge handpiece permits visualization and photocoagulation of the ciliary processes from the anterior or posterior segment.
Q. Can you explain how ECP is performed? The surgeon must decide whether a limbal or pars plana approach is to be used, as well as consider the patient's lens status. Most ECPs are performed at the time of cataract surgery. Typically, after the IOL has been implanted, the ciliary sulcus is inflated with a viscoelastic. This pushes the capsular bag and IOL posteriorly and bombes the iris anteriorly. The endoscope is inserted through the cataract wound and the pupil, (Figure) posterior to the iris. Typically, 300Þ is lasered, the endoscope and viscoelastic are removed and the wound is managed by a surgeon's preference.
Q. What led you to develop this technology? I started my practice in the early 80s and was unhappy with the treatments for neovascular glaucoma. I read a couple of articles on the transvitreal approach to neovascular glaucoma treatment, which had the eye undergo a vitrectomy and a lensectomy followed by scleral depression of the ciliary processes into the view of the operating microscope. An endophotocoagulation probe was inserted through a pars plana incision and the ciliary body was lasered under direct visualization. This treatment had a high success rate with few complications, but was impractical when considering the larger universe of glaucoma patients. It occurred to me that if an endoscope could be made small enough with sufficient resolution to work in the eye and deliver laser treatment simultaneously, it would be useful for many glaucoma patients. I thought surely someone had already created this product. To my surprise, this was not the case.
The first iterations of the laser endoscope were 20-gauge [20-gauge is 0.89 mm] but had lower resolution than what is used today. Still, the treatments for these patients were highly successful. FDA approval for ECP and retinal laser application were received in 1991. Shortly after that, Steve Kohn and I founded Endo Optiks.
Later on, we found that combining cataract surgery with ECP in the setting of uncontrolled glaucoma proved to be effective. Richard J. Makool, M.D., suggested that we try ECP combined with phaco in the setting of medically controlled glaucoma not for the purpose of lowering IOP per se, but for diminishing the patient's long-term need for medications. He proposed that if this approach was even moderately successful and proved to have little downside, then it would be an advance for surgeons and patients. He performed the first comparative study of phaco-ECP vs. phaco alone in the setting of cataract and medically-controlled glaucoma. His data revealed that only about 9% of the patients who had phaco only diminished their long term requirements for glaucoma medications; however, about 80% of the phaco-ECP patients decreased at least some of their medicines and about 60% discontinued all of their glaucoma treatment. There are at least 3 major studies that have been completed and are being prepared for publication. The data we have seen so far corroborate Dr. Makool's.
Q. What does ECP offer to the glaucoma
specialist? ECP represents a complete departure from other surgical methods. Most
of the knowledge required to manage glaucoma by traditional methods is irrelevant
for ECP. Factors such as preoperative IOP, number of medications,
mechanism
of glaucoma, lens status and number of previously failed procedures are of little
relevance to the technical performance of ECP, its postop management and the clinical
outcome. Ophthalmologists can address a large number of their phaco patients who
are using glaucoma medications.
Q. Are transcleral cyclodestructive procedures associated with severe complications? One might assume complications are the consequence of tampering with the ciliary body, but that is untrue. Rather, they are related to the transcleral route of administration. These problems arise from poor targeting of the ciliary epithelium due to the blind nature of the approach, as well as damage to the ciliary vessels. Laser endoscopy permits imaging of the processes with highly titratable and controlled laser delivery. ECP is specifically ablative to the epithelium of the processes sparing the underlying structures. When the "transcleral" surgeon is exploding the processes, pars plana, retina and iris, as well as obliterating the blood supply to the ciliary body by using the transcleral route, then severe complications may arise.
On the other hand, ECP has rarely been associated with complications, and except for neovascular and pediatric forms of glaucoma, there has never been a reported case of hypotony or phthisis. Finally, unless a dense and extensive ECP is performed, the effect on IOP is minimal. OM
ECP Study Results Stanley J. Berke, M.D., and colleagues performed a large prospective comparative study to examine the efficacy and safety of this approach vs. phaco alone. Although the data are preliminary, there were 986 patients in this study with a mean follow-up of 31.2 months (range 6 to 57 months). The phaco-ECP group included 806 eyes. The
mean preoperative IOP was 20.9 mm Hg (+/-5.10 mm Hg) and at the last postoperative
visit was 18.7 mm Hg (+/-3.4 mm Hg) (P=.0001). The 203 eyes in the phaco
alone group had a preop IOP of 21.1 mm Hg The phaco-ECP group used 2.51 (+/-0.88) glaucoma medications preop and 1.0 (+/-0.52) medications postop (P=.0001). The phaco alone control group used 2.44 (+/-0.48) medications preop and 2.41 (+/-0.53) medications postop (P=.90). By the last follow-up visit 91% of the phaco-ECP patients had controlled IOP on fewer glaucoma medications, while only 26% of the phaco-alone patients experienced a similar outcome. Cystoid macular edema was documented in 0.8% of the phaco-ECP eyes compared to 0.7% in the phaco alone group (P=.83). There were no other serious complications in either group. In this large long-term comparative
study, it was observed that adding ECP to phaco was effective in diminishing Finally, adding ECP to phaco did not increase the risk of complications compared to phaco alone. |