Hydroview IOL performed well in multicenter trial

The hydrophilic acrylic lens offers many of the same benefits as PMMA lenses but with a foldable design.

KOLOA, Hawaii — The Hydroview IOL from Bausch & Lomb offers outstanding visual performance, a full optical zone without haptic intrusion and a unique foldable delivery system, according to a clinical investigator.

“They’re going to make some changes that I think are going to make [the lens] even better,” said Douglas A. Katsev, MD, here at Hawaii 2001, the Royal Hawaiian Eye Meeting, sponsored by Ocular Surgery News in conjunction with the New England Eye Center.

Dr. Katsev, who participated in the clinical studies for Food and Drug Administration approval of the Hydroview, also listed excellent biocompatibility as an advantage of the lens.

Another advantage of the Hydroview is that it has the characteristics of a PMMA lens, but with a foldable design. “It had outstanding visual performance. The full optical zone without any haptic intrusion is a definite advantage. ... I’ve put a lot of hydrophilic lenses in as my lens of choice and I just do not see a problem,” he said.

Blended design

---The lens is in perfect position, both haptics are in the capsular bag, and the optic is perfectly centered.
(PHOTO COURTESY OF GUILLERMO PEREIRA, MD.)

The Hydroview IOL has an overall lens length of 12.5 mm and an optic of 6 mm. It has a hydrophilic acrylic optic with PMMA haptics blended into the optic material.

“It’s got a unique design which allows this flexible acrylic to bond to this PMMA haptic,” Dr. Katsev said. “If you play with this lens you’re surprised that it’s a three-piece lens. It really behaves as a one-piece lens. This gives it excellent stable centration.”

The lens has a center thickness that is consistent throughout its range of powers. The refractive index of the optic material is 1.475.

Clinical study

The Hydroview IOL U.S. clinical trial was a multicenter, 3-year trial in which 183 eyes were implanted with the lens. Dr. Katsev studied 22 of those eyes.

Dr. Katsev said he did not experience any trouble with posterior capsular opacification (PCO) at the 6-month follow-up. Ten eyes in his portion of the study (45.5%) had no PCO and 12 eyes (56%) had trace to mild amounts of it. There were no eyes with moderate or severe PCO at 6 months.

Of the overall multicenter group at 3 years, 71 eyes (51%) had no PCO, 49 eyes (35%) had mild PCO, 19 eyes (14%) had moderate PCO and one eye had severe PCO. There were 43 eyes at 3 years that received a YAG capsulotomy.

“If you look at the PCO after 3 years of the overall group, about 20% of the people had YAGs after 3 years,” Dr. Katsev said. “But there is significant grade 2 amount of PCO where their vision wasn’t that bad, but in reality you could maybe throw this into the YAG group. If you speculated those people would have been a YAG to achieve better acuity, we’re about 30% PCO rate after 3 years. I think that’s pretty compatible with any of the PMMA lenses that I’ve put in.”

Most of the patient’s in Dr. Katsev’s group were within 1 D of emmetropia after they were implanted with the lens. The majority were “right on,” he said.

Dr. Katsev had 10 eyes (46%) with 20/20 or better best corrected visual acuity and 21 eyes (96%) with 20/40 or better. These percentages correlated very closely with those from the entire study group, he said.

He said the relatively low percentage of patients at 20/20 was because of a strict study protocol that dictated when YAG posterior capsulotomy could be performed.

“There was a significant number of people that would be 20/25, and in California patients expect more and want laser YAG to improve visual acuity. ... But in the study we specifically had protocol when we YAGed. So I think my percentage of people 20/20 in a normal situation would have been much higher.”

Bausch & Lomb plans to launch the Hydroview lens in the United States later this year.

For Your Information:

• Douglas A. Katsev, MD can be reached at Santa Barbara Medical Foundation, Ophthalmology, 29 West Anapamu, Santa Barbara, CA 93101; (805) 681-8950; fax: (805) 568-1933; e-mail: katsev@aol.com. Dr. Katsev has no direct financial interest in the products mentioned in this article, nor is he a paid consultant for any companies mentioned.

• More information on the Hydroview IOL can be obtained from the manufacturer, Bausch & Lomb, 555 W. Arrow Highway, Claremont, CA 91711; (800) 553-2020; fax: (909) 399-1525.