Personal history of the silicone phakic posterior chamber intraocular lens

Article information

Insights Cataract Refract Surg. 2025;.icrs.25.001

Publication date (electronic) : 2025 February 18

doi : https://doi.org/10.1234/icrs.25.001

Kenneth J Hoffer^,1,2

¹Stein Eye Institute, University of California, Los Angeles, CA, USA

²St. Mary's Eye Center, Santa Monica, CA, USA

Correspondence to: Kenneth J Hoffer St. Mary’s Eye Center, 411 Lincoln Blvd, Santa Monica, CA 90402, USA Tel: +1-310-387-2013, E-mail: KHofferMD@StartMail.com

Received 2024 September 20; Revised 2024 September 23; Accepted 2024 October 28.

I first became interested in the posterior chamber phakic intraocular lens (IOL) in 1996 when I had heard that STAAR Surgical in California was beginning a US Food and Drug Administration (FDA) study on what they called the intraocular contact lens (ICL) which was made of Collamer. Knowing him very well, I drove to John Wolf’s office (president of STAAR) to ask him if I could be an investigator. His response was a simple “NO!” I never asked why and then tried to think of other ways to get to try the lens and was unsuccessful until the day I was giving my annual course on “IOL power calculation” at the American Academy of Ophthalmology meeting in September 1996. After presenting the future possibility of needing to calculate the precise IOL powers for posterior chamber phakic IOLs, a lady in the audience jumped up and stated “We are implanting them in New York.” I was shocked and told her to wait for me at the end of the course.

After talking to her, I discovered her name was Diane Hatsis, RN, a registered nurse and she told me her brother Alexander Hatsis, MD of New York City was implanting them under an FDA investigational device exemption (IDE) that had been obtained through George Rozakis, MD of Ohio. I couldn’t believe this was possible. I contacted Dr. Hatsis and he put me in contact with Dr. Rozakis who told me there was a special meeting of the company from Ohio making the lenses called International Vision Inc. (IVI) at the next American Society of Cataract and Refractive Surgery (ASCRS) meeting in Boston in April 1997. He said he would get back to me with the exact date and time, which, of course, he never did.

In April, I arrived from the train in Boston and after checking into my hotel room, I went down to their counter bar to get a beer. A man came in with a wet heavy coat lugging several bags and squeezed into the seat right next to me. We struck up a conversation and as I looked at him, he looked familiar. I asked him if he was George Rozakis and he said yes. I then told him who I was and asked why he never contacted me. He apologized and told me the IVI meeting was the next day at 6:30 PM and he gave me the room number. What a fortuitous happening! Otherwise, I would have missed it completely.

The next day I was eager to get to the meeting. When I walked in, I was introduced to the President and owner of IVI, Mr. Jacob (Jake) Feldman, an engineer who had emigrated from Ukraine in 1978. He told me to get in line to meet their chief investigator, Dr. Dimitrii Dementiev (a Russian [Moscow] from Milano, Italy) (Fig. 1).

Fig. 1.

Dimitrii Dementiev, MD and the author in 2015.

After the ASCRS meeting, I was to fly to Paris on an Air France Concorde SST to spend 3 months traveling through Italy with my wife, Marcia. In preparation I spent a lot of time studying to speak Italian (not totally successfully). When I reached Dimitrii, I said “Come esta?” Just ahead of me, was Alex Hatsis who had gone to medical school in Italy and he greeted Dimitrii in Italian as well. Dimitrii responded to me “Does everyone here in America speak Italian?” After that he and I hit it off very well and I told him I would be in Italy next week, so he invited me to visit him in Milano. I then rearranged my travel plans so I could get to Milano earlier.

From that IVI meeting I learned that the first posterior chamber phakic IOL (mushroom lens) (Fig. 2) was invented in August 1982 by Prof. Viktor Zuev (died 2022) working in the Moscow Eye Institute under its Chairman, Dr. Syvatoslav Fyodorov, who introduced Radial Keratotomy (RK) to the West. Fyodorov also introduced the phakic IOL in the West, therefore no one has ever heard of Prof. Zuev.

Fig. 2.

The original (1982) Zuev silicone posterior chamber phakic intraocular lens to correct ametropia.

Jake ultimately wound up in Cincinnati, Ohio working for J&J. He started IVI in 1996 and brought Igor Valunin from Moscow to make the silicone and help produce the phakic IOLs. After starting IVI, he met up with Rozakis who worked with Jake to draw up an FDA IDE application which was accepted. This was a remarkable feat. After animal studies in Russia and Mexico, under the IDE, Rozakis and Hatsis began implanting the lenses to correct myopia and hyperopia (Fig. 3). Hatsis implanted the first IVI silicone phakic IOL in America in New York City on July 26, 1996 (almost 30 years ago).

Fig. 3.

Medennium phakic refractive lens for myopia and hyperopia.

Dimitrii was trained and worked at the Moscow Eye Institute becoming 2nd in command there under Fyodorov. He knew all the work Zuev had done on his Phakic IOL and was implanting them. After he escaped from his Soviet Union KGB (Committee for State Security) handlers while in Bari, in 1989, he gravitated to Milano, Italy and set up a practice there. He started performing phakic IOL surgery and received some press interviews in local newspapers which was heavily frowned upon by his local Italian colleagues.

After we arrived in Europe, we immediately drove to Milano and met Dimitrii and his wife Tania. We had a memorable dinner in which he introduced me to the newly popular Italian drink called limoncello. When I asked if I could see him perform some phakic IOL surgery, he asked me to meet him in Bari, Italy (in Puglia in the southeast coast) in one month. We left Milano, traveled south to the “Toe” of Italy, crossed the Strait of Messina, did a circle around the island of Sicily and returned to the mainland across the southern coast of Italy and then north to finally arrive in Bari on the precise date he recommended.

He was doing surgery in the offices and operating rooms of Gianfranco Sborgia, MD (died 2020) in Bari, Italy. Sborgia had visited Fyodorov in Moscow and invited him to do surgery in his center in Bari. Fyodorov wanted to start clinics in the West to promulgate the “Fyodorov Philosophy” and decided to make this one of his first and sent Dimitrii to do it for him—that is where Dimitrii found a way to lose his KGB followers in 1989. On May 24, 1997, I assisted him performing two cases of phakic refractive lens (PRL) implantation. He is an excellent surgeon and a very good teacher. It was interesting that we did not use gloves and had special techniques to maintain sterility. When I asked him why, he told me that is the way they do it here in the South of Italy (this was 1997). While scrubbing for the 3rd case, he told me that I would do the next case. I was quite surprised, a touch nervous, but excited to be able to do my first phakic IOL. She was a 24-year-old student with a –14.25 sphere left eye (OS) and no cylinder and I would implant a –15.0 diopter (D) PRL. Everything went fine but as I was trying to push the distal haptics far enough distally under the iris with the forceps (so that I could get the proximal haptics in the eye) he shouted at me “Don’t push too hard!” I eased off and was ultimately able to manipulate it in successfully. That warning was meant to protect the zonules so as not to damage them. If they are broken, it could lead to the PRL sliding back into the vitreous later; a warning I long remembered.

I examined Salvatora Zizzi the next day with Dr. Sborgia (Dimitrii had to leave Bari that morning). She looked perfectly fine; her cornea was clear, the PRL was in place and she had good unaided visual acuity. I was pleased. Unfortunately, I was never able to see her again. On follow-up by Dimitrii, on November 2nd (5.3 months) she was 20/25 uncorrected visual acuity (UCVA) and corrected to 20/20 with a ‒1.00 D refraction. Exactly 1 year postoperative (PO), she was 20/25 UCVA and corrected to 20/20 with a –0.75 D refraction and no complications. Needless to say, my enthusiasm for the PRL was highly increased. We left Bari the next day to continue our 3 months in Italy. When I returned home, I kept in contact with Dimitrii, Jake and Rozakis.

I persuaded Dimitrii that we start a surgical course only for American surgeons to learn about the PRL in Bari. We coordinated all of the details via email, including designing the course with lectures, surgical observation, examining one day and longer term postoperative patients and setting up and printing a complete course manual (Fig. 4A). The first course was held in Bari in the summer of 1998, which I was not able to attend, but Dimitrii did an excellent job with 20 American attendees. We successfully repeated this in June 1999 in Milano with another 20 American attendees and I attended and participated in this one (Figs. 4B, 5).

Fig. 4.

Hoffer-Dementiev Second International Course on phakic refractive lenses in Milano, Italy June 24‒26, 1999. (A) Course manual. (B) Drs. Hatsis, Dementiev, and Hoffer during the lecture period.

Fig. 5.

(A) Dr. Dementiev performing phakic refractive lens surgery for course attendees. (B) Dr. Dementiev and attendees examining the postoperative patients the next day.

In 1996, Rozakis started an investment fund he called the Vision Venture Fund (VVF) to help the IVI company to expand and start a full FDA study. Many of us contributed and later most of us lost our investment. Jake had started an ownership relationship with CIBA Vision (Novartis) and they were monitoring the FDA study of the PRL for approval and sales in the United States. While in London (on our 3 month UK-Ireland trip) in the summer of 1999, Jake telephoned me and asked if I would be the medical monitor for their FDA study. I agreed, with the caveat that I be the 1st to implant one in the US. As medical monitor, I helped work on the protocols for the study. One item I mandated was that Dimitrii had to be present for each new investigator’s 1st PRL surgery. Thus for each investigator, Dimitrii flew to their city for each of their first PRL surgeries. I think this made a tremendous difference. I also successfully persuaded the company to change the name of the lens from ICL (which I thought was inappropriate; it is not really a contact lens) to PRL, I published it [1]; the name stuck and was also trademarked by Medennium.

In late 1999, as I was excitedly preparing to do the first PRL in the US, Jake informed me that Charles Fritch, MD of Bakersfield was selected to do the 1st case that September. Needless to say, I was quite disappointed. Finally, in December of 1999, Dimitrii flew over to assist in my first PRL. The study went well with all the investigators doing their cases and filling out the protocol forms all under the monitoring of CIBA Vision. By the end of the study, I had implanted 20 PRLs including one in the eye of a member of my staff who was a monocular +6.00 D hyperope. During this time, I invented a new method to easily perform the mandatory peripheral iridotomy needed before the hole was added to the phakic IOLs. I called it a peripheral vacuum iridotomy [2] which involved making only a tiny snip in only the the iris stroma through an incision and then using a blunt needle to carefully vacuum the pigment layer into the syringe. This left a secure tiny through-and-through opening way in the periphery. This prevented the possibility of glare from an overly large iridectomy (which often occurred attempting to remove both layers) and eliminated pigment blocking the trabecular meshwork (which often occurred with laser iridotomies).

The problem with a study of this kind is that the majority of patients arm young and quickly get lost to follow-up. This is because they are happy with their uncorrected vision and feel no need to keep returning for visits just because you are doing an FDA study and many move to other areas. David Bailey, the President of CIBA Vision left to become the CEO of STAAR Surgical and moved his home from the US to Switzerland just as the company was preparing the FDA submission. In analyzing the data, they discovered that there were no PRLs that slipped into the vitreous but one of the investigators had an abnormally high endothelial cell loss in his cases. In the process of all this, they abandoned the FDA study and unfortunately, that was the end of the PRL in America.

From 1999 to 2004, Dimitrii and I published four textbook chapters [3‒6] on the PRL and it uses. Jake had obtained a CE Mark in the EU and was also selling PRLs in Asia. Then came the fateful year in 2002 [7] when we learned there were a number of surgeons in Spain who experienced the PRL sliding back into the vitreous. My theory on this was that they did not hear or did not heed Dimitrii’s warning regarding damaging the zonules on insertion. There were publications about this issue and the word spread throughout Europe. Now that was the beginning of the end of the PRL in the EU. This is a horrible shame in that the reason for its demise was based simply on surgical technique both in the US (silicone contacting endothelium) and in the EU (breaking zonules). In 2000, Jake changed the name of the company to Medennium and worked with Dimitrii to make several changes in the PRL design including adding a hole in the optic so as to eliminate the need for an iridotomy. He therefore changed the name of the lens to Medennium Phakic Lens (MPL).

In 2023, Jake sold Medennium to the DeCheng Investment group who hired Sid Wei, PhD as CEO. Dr. Wei has been in the process of looking to the future for the MPL and is on a path to opening other worldwide markets, changing the MPL design to increase its stability so that a Toric MPL can be successful and looking to begin a US FDA study in America in the near future. Many MPLs have been implanted in the EU, Asia and other parts of the world but, unfortunately, little data has been carefully collected to evidence its success in publications. We hope to correct that.

My general feelings about the STAAR ICL (FDA approved) and the Medennium PRL/MPL is that the former is made of collamer, is quite radially stable (allowing Toric correction) but can cause anterior capsular cataracts. The Medennium MPL is made of silicone, does not cause cataracts but does have instances of radial rotation (barring Toric correction) and rare instances of zonular damage if the surgeon is not careful during insertion. I look forward to the changes being made in the MPL design and an upcoming FDA study.