None listed
Conditions
Brief summary
The closure of corneal wounds during cataract surgery remains reliant upon sutures, self-sealing corneal incisions, or tissue adhesives. Each of these methods have disadvantages, including time-consuming procedures, distortion of the eye’s shape, increased risk of endophthalmitis, wound leaks, lack of mechanical strength and toxicity to the ocular surface. We have developed a thin, laser-activated chitosan adhesive film that can be rapidly applied to the eye for sutureless sealing of corneal wounds. In this study, we propose to demonstrate the safety and efficacy of our adhesive film-based technology, termed ‘Kleer-i’, in sealing corneal wounds for the treatment of corneal wound incisions created during cataract surgery. The film may allow for quicker surgery, rapid healing and prevent the risk of complications such as scarring, infection and wound leakage.
Interventions
Patients will undergo routine cataract surgery performed by Professor Stephanie Watson (Ophthalmologist). The Kleer-i adhesive film will then be applied over the main corneal wound incision by Dr Damien Le (Principal Investigator/Ophthalmology Registrar). The film will be irradiated by a laser for 45 seconds. This will only occur once at the end of the surgery. The procedure will be documented in the operation report.
Sponsors
Corneal Research Group - Save Sight Institute, The University of Sydney
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The following inclusion criteria will be used for patients: • Patients with age-related cataract and expected to undergo clear cornea cataract surgery with phacoemulsification and implantation of posterior chamber intraocular lens • Patients must be 55 years of age or older • Patients with well-managed diabetes can be included • Post-menopausal women can be included • Willingness to give written informed consent • Willingness to participate and comply with the study • Ability to read and understand English language
Exclusion criteria
Patients will be excluded if they meet any of the following criteria: • Patients on topical therapy for any ocular conditions • Inability to read and understand English language • History of herpes simplex or zoster keratitis • Recent eye infection (microbial keratitis or conjunctivitis) within the last 3 months • Pseudoexfoliation syndrome • Patients with the following autoimmune disease; Sjogren’s syndrome, cicatrising conjunctivitis secondary to ocular cicatricial pemphigoid, peripheral ulcerative keratitis including Mooren’s ulcer, uveitis, retinitis and Grave’s disease. • Pregnant women • Patients with allergy or sensitivity to 3 or more medications • Previous corneal (including refractive surgery) or retinal surgery or planned multiple procedures during cataract surgery • Patients with significant comorbidities such as corneal dystrophy or other opacity • Patients with glaucoma • Patients with any history of ocular surface disease • Patients with corneal disease
Outcome results
None listed