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Sealant helps to increase efficacy in wound closure
A surgeon discusses a multicenter trial and shares cases in which patients benefited from the sealant device.
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In an ideal world, clear corneal incisions would efficiently self-seal in all cataract surgical cases. However, there are a number of cases in which the incision size or other factors can adversely affect the self-sealing nature of these incisions. When these incisions do not seal as they should, until recently, the only alternative to seal the wound was to apply a suture. However, data show that even sutures do not seal as well as previously thought.
Multicenter trial evaluation and results
I participated in a multicenter trial to evaluate the efficacy of wound closure techniques. Specifically, we studied sutures vs. the ReSure Sealant (Ocular Therapeutix), the first FDA-approved hydrogel ocular sealant for wound closure, and examined the results in a subset of patients who had incisions ranging from 3 mm to 3.5 mm after uncomplicated cataract surgery. These large or enlarged incisions are often more vulnerable to leakage in the postoperative period, and many of us use either excessive stromal hydration or sutures to close these incisions, neither of which is ideal for the patient.
Sixty-four patients with a demonstrated wound leak (spontaneous or provoked with up to 1 oz force using an ocular force gauge) were randomized to receive either a 10-0 nylon suture using a 3-1-1 technique with a buried knot (26 patients) or the ocular sealant (38 patients). Incisions were provoked again to test for leakage after device application using up to 1 oz force. Patients were monitored with a Seidel test through day 7 and for safety through day 28.
Leak rates were significantly lower at 2.6% with the sealant vs. 38.5% with a suture. Device-related adverse events were also significantly lower with the sealant, 0% with the sealant vs. 38.9% with a suture.
Adverse events associated with sutures are possible, and sutures should be removed on a regular basis to prevent future complications. The sealant was more effective in sealing the incision and preventing fluid egress in large clear corneal incisions. Additionally, the sealant dissolves within the first postoperative week, eliminating the need for device removal.
Based on the evidence in the study, the sealant was found to be a superior means of wound closure over sutures. This may be especially beneficial in more complicated cases such as those with prior radial keratotomy (RK), corneal transplantation or vitrectomy, those with a possible need for future vitrectomy, and perhaps in cases in which premium lens and femtosecond laser patients pay a premium for the best possible results.
Ideal cases for sealant use
I have utilized the sealant in several different instances after cataract surgery. It is particularly effective in cases in which a patient had prior corneal surgery. In these patients, the corneal incision does not always hydrate as well. Therefore, the incision often continues to leak and typically ends up needing a suture.
The sealant was proven in this data analysis to be beneficial in regard to larger incisions. This may be particularly useful for accommodating lenses that require a slightly larger incision compared with an acrylic lens. Making a good seal is imperative for these IOLs to ensure they remain in the correct position. Patients who do not end up getting as much accommodative effect as expected are often thought to have had a wound leak during the early postoperative period, contributing to the lens vaulting anteriorly.
Case examples
A 62-year-old woman had prior corneal transplantation and developed significant nuclear sclerotic and cortical cataract with vision of 20/60–. She had 3.5 D of cylinder and chose a toric IOL. I performed phacoemulsification and implanted the IOL without any complications, concluding with the application of sealant. On postoperative day 1, the patient had visual acuity of 20/25–, reported very good comfort overnight, and had a well-sealed incision and minimal anterior chamber reaction. There was only a hint of sealant visible on her eye.
A 51-year-old man presented with prior RK with eight incisions, two arcuate incisions and an optical zone of approximately 3 mm. His visual acuity was 20/50 with a significant posterior subcapsular cataract. He had a toric IOL placed for 2 D of cylinder. The incision was placed at the limbus between the RK incisions, ensuring that there was no overlapping incision. I used the sealant at the end of the case instead of suture. When seen postoperatively on day 1, his vision was 20/20– with minimal anterior chamber reaction, and there was a slight bluish color of sealant visible at the well-sealed primary incision site. The patient had no discomfort overnight.
Conclusion
Previously, a significant percentage of complex cataract cases required increased operating room time just testing and retesting to ensure that the wound was properly sealed, leaving me more concerned about wound stability during the postoperative period. In these cases, use of the sealant has eliminated all of that. Technically, the sealant is more costly than a suture. However, when the benefits to the patient are considered, it is apparent the cost of the sealant is worthwhile in many patients. Ensuring a true seal, thus preventing possible leakage and associated complications, is critical to the successful outcome of these procedures. Additionally, when the time saved in the operating room is factored in, as well as clinic time saved by not having to remove the suture, the cost differential may not be as pronounced as it might first appear. Operating room time is expensive, and saving even a minute or two is beneficial. When cost, care, convenience and efficacy are all considered, the sealant is an ideal method to close incisions in appropriate patients.
- References:
- Chee SP. Int Ophthalmol. 2005;doi:10.1007/s10792-007-9031-3.
- Herretes S, et al. Am J Ophthalmol. 2005;doi:10.1016/j.ajo.2005.03.069.
- Masket S, et al. J Cataract Refract Surg. 2014;doi:10.1016/j.jcrs.2014.03.034.
- Mifflin MD, et al. J Cataract Refract Surg. 2012;doi:10.1016/j.jcrs.2012.04.019.
- For more information:
- Rajesh K. Rajpal, MD, can be reached at SeeClearly Vision, 8138 Watson St., McLean, VA 22102; email: rrajpal@seeclearly.com.
Disclosure: Rajpal reports he has been a consultant for and received research funding from Ocular Therapeutix.