Closing cataract incisions: Sealant superior to sutures

October 1, 2014

A hydrogel sealant demonstrated significant superiority to suturing for sealing incisions that were leaking when tested immediately after small-incision phacoemulsification and toric IOL implantation.

 

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A hydrogel sealant demonstrated significant superiority to suturing for sealing incisions that were leaking when tested immediately after small-incision phacoemulsification and toric IOL implantation.

 

Dr. Lane

By Cheryl Guttman Krader; Reviewed by Stephen S. Lane, MD

Minneapolis-A hydrogel sealant (ReSure Sealant, Ocular Therapeutix) prevented fluid egress from leaking clear corneal cataract incisions more effectively than sutures and had a better safety profile in a prospective multicenter study, said Stephen S. Lane, MD.

“Clear corneal cataract incisions commonly leak, even when well constructed, and it is important to prevent these leaks since they can result in a variety of sight-threatening events as well as compromise refractive outcome,” said Dr. Lane, medical director, Associated EyeCare, and adjunct professor of ophthalmology, University of Minnesota, Minneapolis.

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“Although sutures have been the gold standard for closing cataract incisions, they have a leak rate of about 24% according to various publications along with a number of other drawbacks,” Dr. Lane said. “The results of this study indicate the hydrogel sealant offers a better means of wound closure sutures when using toric IOLs.”

About the research

The study included 49 patients operated on at 11 participating centers who were followed at regular visits through 28 days after surgery. All patients had undergone uncomplicated surgery with implantation of a toric IOL (AcrySof IQ Toric, Alcon Laboratories) and had a positive Seidel test at the end of the procedure.

 

Incisions were tested at the conclusion of surgery, and the leaking was either spontaneous or induced by minimal provocation using a calibrated force gauge (Ocular Force Gauge, Ocular Therapeutix) to apply up to 1 ounce of force in 0.25 ounce increments at a location 0.5 mm away from the scleral side.

Patients were randomly assigned 3:2 to incision closure with the hydrogel sealant (30 eyes) or suture (19 eyes). Immediate re-testing of incision integrity showed the sealing rate was significantly higher using the hydrogel sealant group compared with sutures (96.6% versus 57.9%).

During the follow-up, 9 (47.4%) patients in the suture closure experienced a device-related adverse event, of which 6 required suture removal. Only 2 (6.7%) patients in the hydrogel sealant group experienced a device-related adverse event, and in neither case was removal of the sealant required.

Dr. Lane noted that a much larger study would be required to determine the superiority, if any, of using the hydrogel sealant versus sutures in terms of astigmatism outcomes when implanting toric IOLs.

Other study findings

Incision dimensions were similar in the two groups. Mean incision width was 2.7 mm in the suture group and 2.5 mm in the sealant group. Mean tunnel length was 2.5 mm in the suture group and 2.2 mm in the sealant group.

IOP was also monitored during the study and was increased in both groups on the first day after surgery. Mean IOP at baseline in the suture and sealant groups was 13.89 and 16.07 mm Hg, respectively, and rose to 16.21 and 19.87 mm Hg, respectively, on the first day after surgery.

The only adverse events related to use of the sealant were a single case of >2 line loss of best-corrected visual acuity that resolved and a case of corneal astigmatism >3 D. Device-related adverse events in the suture group included one case of corneal astigmatism >3 D, five reports of discomfort/eye irritation/feeling of tightness, two subconjunctival hemorrhages, and one infection. All adverse events in the suture group resolved.

 

Feedback from the surgeons participating in the study indicated the hydrogel sealant was overall easy to use. It is applied as a liquid and gels in situ within 30 seconds. Following corneal re-epithelialization, the sealant sloughs off in the tears.

“One of the disadvantages of sutures is that their use requires an additional visit for removal,” Dr. Lane said. “With the sealant, there is no need to remove the device.”

 

 

Stephen S. Lane, MD

E: sslane@associatedeyecare.com

This article was adapted from Dr. Lane’s presentation at the 2014 meeting of the American Society of Cataract and Refractive Surgery. Dr. Lane is a consultant with Ocular Therapeutix.