Punctal plug proposed for glaucoma treatment

ATLANTA – A researcher reported here at the annual meeting of the American Academy of Ophthalmology that a novel punctal plug approach to glaucoma drug delivery appears well tolerated and lowers IOP.

“Punctal plug delivery represents a novel approach to problems of medication compliance by delivering medication over 3 months,” Richard A. Lewis, MD, said.

The punctal plug delivery system works by eluting latanoprost from a core in the punctum plug.

Dr. Lewis and colleagues conducted an open-label, uncontrolled pilot study and a randomized phase 2 study examining IOP reduction and tolerability using the punctal plugs. The pilot study examined 3-month drug release results of 10 eyes of five patients with primary open-angle glaucoma or ocular hypertension.

Pressure was reduced by 30%, Dr. Lewis said, and the device was well-tolerated and had no side effects.

However, the retention rate using a commercial plug was not optimal, at 63%, he said.

The second phase of the study is examining 61 glaucoma patients. Preliminary results showed a statistically significant drop in mean IOP from baseline, he said.

Additional highlights from the AAO meeting appear below.

Member survey results

LASIK continued waning as lens-based refractive procedures gained ground in certain cases in 2008. Refractive surgeons and their families are more likely to undergo refractive surgery than the general population, according to a physician.

Richard J. Duffey, MD, presented results of the 2008 ISRS/AAO Member Survey during Refractive Subspecialty Day.

Refractive surgeons and their families have undergone refractive surgery themselves at four times the rate of the general population, Dr. Duffey said.

“The take-home message is … [there is a] 35% penetration among ourselves having refractive surgery on our own eyes, and that’s four times the general population and an even greater family index,” he said. “Figure only about half of us are eligible, so that’s a significant number.”

For 10-D myopes, about half of members preferred phakic IOLs. For 3-D hyperopes, about two-thirds of members preferred LASIK, but refractive lens exchange continued to gain. For 5-D hyperopes, two-thirds preferred refractive lens exchange over LASIK, Dr. Duffey said.

Results also showed 17% of members approve of bilateral phakic IOL implantation, up from 10% the previous year.

Surgeons preferred a flap thickness of 100 µm to 130 µm; 52% approved a minimum residual stromal bed of 250 µm, and 47% preferred a residual stromal bed of more than 275 µm or more, Dr. Duffey said.

Cornea techniques derived from refractive surgery

Innovations in cornea transplantation have come from lessons learned in refractive surgery, Roger F. Steinert, MD, said in the Barraquer Lecture.

“My theme for the day is that corneal surgery is now also refractive surgery,” Dr. Steinert said.

He and colleagues are involved in a femtosecond laser-based project for corneal transplantation, using a zigzag technique that attempts to solve some of the problems that can result from the traditional procedure, he said. These include rotational alignment of the anterior surfaces of the donor and host as well as alignment of the donor in the host, integrity of suture tension and postoperative uneven wound healing.

A study by Dr. Steinert and colleagues compared 46 eyes of 40 patients undergoing laser cornea transplantation, with 17 eyes of 14 patients undergoing conventional procedure. At 3 months, in patients with 20/20 potential, 30% of eyes undergoing conventional surgery were 20/40 or better, whereas 80% of eyes undergoing laser surgery were 20/40 or better, Dr. Steinert said.

Anti-VEGF better treatment for DME

Diabetic macular edema regresses more after treatment with ranibizumab rather than laser photocoagulation or combination therapy of ranibizumab plus laser photocoagulation, a presenter said.

The results of the READ 2 (Ranibizumab for Edema of the Macula in Diabetes phase 2) Study show “a mean improvement in visual acuity over time, and you see that in the ranibizumab-alone group, it was a mean improvement of roughly eight letters, which is close to the READ 1 trial,” Peter A. Campochiaro, MD, said.

Keynote speaker urges ophthalmologists to collaborate with optometrists Harvey V. Fineberg, MD, PhD, called for a truce between ophthalmology and optometry in his keynote address at the American Academy of Ophthalmology annual meeting. Image: Altersitz K, PCON ATLANTA – The keynote speaker at the American Academy of Ophthalmology meeting urged his colleagues to consider more collaboration with optometry while creating more value in their own specialty. “It’s time for a truce in the hundred years’ war between ophthalmology and optometry,” Harvey V. Fineberg, MD, PhD, said during the opening session. “It’s time to stop harping endlessly on what optometrists cannot do and to begin thinking critically and effectively and working to figure out what optometrists can do.” As health care faces various economic and demographic changes and challenges, ophthalmology is poised to take the lead in meeting those challenges, he said. “I believe that ophthalmology has an opportunity not only to play a part in the solution but to be an exemplar for health care moving ahead to meet these challenges,” Dr. Fineberg said. Health care specialties need a renewed commitment to research and innovation, he said. “This innovation must be aimed not only at improving quality but must also be aimed simultaneously at increasing value, doing more for less, organization,” Dr. Fineberg said.

“It was significantly better than the combination group, which had a 3.8-letter improvement, and the laser group, which had a one-letter loss,” he added.

The trial looked at 115 patients randomly assigned to either 0.5 mg of ranibizumab, focal laser or a combination of the two. In the ranibizumab-only group, patients received two injections monthly, then every other month to match up with the combination group that had an injection, then 1 month later they had laser.

About half of the central foveal thickness in the ranibizumab-alone group was lost, but READ 1 showed an 87% decrease, Dr. Campochiaro said.

“These patients with this protocol seem to be somewhat undertreated,” he said.

Both the laser and combination groups had substantial residual thickness.

Sulcus IOL safe, effective

A new sulcus IOL is a safe, versatile alternative to existing refractive lens exchange options, according to a study.

Michael Amon, MD, described 1-year results for the Sulcoflex IOL (Rayner) at Refractive Subspecialty Day.

“In my opinion, the Sulcoflex is a promising new IOL concept with various new indications,” Dr. Amon said.

The lens showed low rates of interlenticular opacification, depigmentation and tilt. It also provided good centration and visual acuity as well as stable refraction, he said.

The Sulcoflex, a supplementary IOL, is indicated for postoperative emmetropia, astigmatism, higher-order aberrations and pseudophakic presbyopia, Dr. Amon said.

The single-piece, hydrophilic acrylic IOL has a posterior convex surface and soft haptics with rounded edges. Its 6.5-mm optic fits on the anterior convex surface of the primary IOL. The lens was implanted into the ciliary sulcus of pseudophakic eyes, he said.

DSEK similar in glaucoma, nonglaucoma patients

There were similar positive outcomes in visual acuity for glaucoma and nonglaucoma patients after Descemet’s stripping endothelial keratoplasty, but because of high IOP in both groups, postoperative pressure should be carefully monitored.

Thasarat S. Vajaranant, MD, presented results of a retrospective review of visual acuity and IOP in 315 control eyes and 85 glaucoma eyes after Descemet’s stripping endothelial keratoplasty (DSEK).

“After DSEK, history of pre-existing glaucoma did not appear to be associated with poor outcomes,” she said.

Dr. Vajaranant and colleagues found that the incidence of elevated IOP after DSEK was high in both control eyes (37%) and glaucoma eyes (51%). However, this did not appear to affect visual outcomes. The mean visual acuity improvement at 12 months was two lines in the control group and three lines in the glaucoma group, she said.

Dr. Vajaranant’s presentation on DSEK in glaucoma patients was awarded Best Paper of the glaucoma original papers session.

Anti-VEGF effective for DME

At 12 months follow-up, ranibizumab was shown to be beneficial in treating diabetic macular edema, a surgeon said.

Pascale G. Massin, MD, presented results from the phase 2 RESOLVE study. Image: Altersitz K, PCON

“Results from the phase 2 RESOLVE study indicate that DME responds to treatment with intravitreal ranibizumab. Efficacy in ranibizumab-treated patients showed clinical and statistical superiority vs. sham treatment in terms of mean average change in best corrected visual acuity and central retina thickness,” Pascale G. Massin, MD, said.

The multicenter double-masked study looked at 151 patients randomly assigned to one of two doses of Lucentis (ranibizumab, Genentech) or sham treatment; 42 patients were analyzed at 6 months, and 109 were analyzed at 12 months. Investigators had the opportunity at 1 month to double either of the ranibizumab doses, with the 0.3-mg dose going to 0.6 mg and the 0.5-mg dose going to 1 mg.

“Retinal VEGF levels may be considerably higher in the retina and vitreous of patients with DME than in patients with neovascular AMD,” Dr. Massin said in her presentation, which won Best Paper of the retina/vitreous original papers session.

Mean BCVA in the 102 patients treated with either dose increased by a mean of 7.6 lines, and mean central retinal thickness decreased by more than 150 µm.