RLE accompanied by ethical considerations

Las Vegas-Refractive lens exchange (RLE) is associated with an increased burden of informed consent disclosure because of the complex issues, both current and future, accompanying that procedure, said Douglas D. Koch, MD, at the Refractive Sur-gery Subspecialty Day during the American Academy of Ophthalmology annual meeting.

“I submit that the burden is greater than what we face when performing corneal refractive surgery because of the higher risk of severe vision loss and the elimination of more future options with RLE,” said Dr. Koch, professor and holder of the Allen, Mosbacher, and Law Chair in Ophthalmology, Baylor College of Medicine, Houston. “In addition, it is greater than for cataract surgery because, in contrast to patients who need to undergo removal of an opacified lens with IOL placement, the RLE patient has other options available.

“RLE is a procedure that can provide superb visual results, however, and there are lots of happy and satisfied post-RLE patients,” Dr. Koch continued. “Adequate informed consent mandates that the surgeon devote extra time and attention, but it is the basis for increasing the likelihood that patients who undergo RLE will enjoy the full rewards of this exciting procedure.”

Dr. Koch reviewed the benefits, risks, and alternatives that should be included in the RLE informed consent discussion.

Explanation of the benefits should include a description of the postoperative refractive options, which consist of monovision or implantation of a presbyopia-correcting IOL, along with descriptions of expected vision outcomes.

Patients need to be educated about the zones of best focus with the various multifocal implants and that the best outcome depends on binocular implantation.

“Using a contact lens trial, it is possible to simulate for the patient what monovision will be like,” Dr. Koch said. “However, there is no opportunity for a preview of the vision outcome after implantation of a multifocal or accommodative IOL.”

The inability to simulate vision in the latter situations leads to the notion of risk. In that regard, the physician-patient discussion must include an explanation of the potential for quality-of-vision problems with various types of IOLs.

These include halos with accommodative or multifocal IOLs and reduced contrast sensitivity with the multifocal implants. The fact that long-term experience is minimal with accommodating IOLs is another topic that must be reviewed.

“The longest available follow-up with these implants is only about 3 to 4 years, so the long-term efficacy of accommodating designs is unknown, and there is the potential for new issues to emerge over time,” Dr. Koch said. “I am also concerned about the impact of age-related ocular disease on eyes with multifocal IOLs.”

As examples of the latter, he mentioned that he has seen a few RLE patients with multifocal IOLs implanted who have developed macular degeneration and are more hampered by it because the pseudo-phakic implant has reduced their contrast sensitivity.

Furthermore, questions remain about a possible risk associated with implanting an IOL that only filters UV light up to 350 nm, he said.

Discussion of risks

The risk discussion also must cover the classic sight-threatening complication of endophthalmitis that can occur with any intraocular procedure and, for patients with axial myopia, retinal detachment.

For all potential risks, information provided should include data about the frequency of the events and their outcomes, Dr. Koch said.

In explaining alternatives, surgeons should review the various IOL choices available to the RLE candidate as well as alternatives. Topping the latter list are currently available options, such as laser-vision-correction procedures or myopic phakic IOLs, as well as those on the horizon, such as the corneal pinhole implant (AcuFocus) and intracorneal lenses. Patients also should be informed, however, that future RLE procedures undoubtedly will be superior to current ones.

“We can expect new advances will bring improved IOL designs that will provide better quality-of-vision outcomes,” Dr. Koch said. “Patients need to be aware of those options, especially in the realm of better accommodating designs, and we must be sure that they understand that they will no longer be available for them if they undergo RLE now.

“Furthermore, future lens procedures will likely be safer as we can expect developments that will result in better protection against endophthalmitis and the development of posterior capsule opacification,” he added.

Dr. Koch told his colleagues that he often is asked how he answers patients who ask what he would do if he were standing in their shoes. He noted, however, that he believes it is not possible to answer that question.

“There is no way surgeons can place themselves in a patient’s situation considering variations in visual needs and adaptation,” Dr. Koch said. “Telling the patient that you would undergo RLE could talk someone into surgery who should not get it, while saying you would not have the procedure could convince someone to decline RLE who might turn out to be very satisfied.

“Instead, surgeons should [devote] the time and attention necessary to discuss all of the complexities involved so that patients can make their own informed decision,” he concluded.OT