| First in Human (FIH) Study to Assess Safety and Efficacy of the CorNeat KPro for the Treatment of Corneal Blindness Litvin et al. (2021)
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Study enrolled 40 participants and the CorNeat KPro is to be implanted unilaterally with follow up procedures being performed at day 1, week 1, and months 1,2,3,6, 9, and 12 following implantations. Clinical assessment of the keratoprosthetics will be done through examination of the eye using slit-lamp biomicroscope, intraocular pressure measurement and ocular imaging Litvin et al. (2021). Further, participants’ visual acuity will be assessed and recorded through the 13 months follow up period |
There are no posted results of the ongoing study. One patient who underwent corneal transplants had visible improvement of the corneal repair |
| Safety and Indicative Effectiveness of Porcine Corneal Lenticular Implants in Patients with Advanced Keratoconus and Post Lasik Ectasia: A Retrospective Clinical Study Wilson et al. (2022)
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A retrospective clinical study aimed at o evaluating the safety and feasibility of implanting decellularized porcine corneal lenticules in a femtosecond laser-assisted pocket for patients with advanced keratoconus and post-Lasik ectasia |
Visual acuity improved in all patients except for one case at 6 and 12 months (p = 0.002 and 0.007). At 1-year follow-up, the mean central corneal thickness increased from 389.43 ± 45.41 to 429.33 ± 63.20 µm, the maximum keratometry decreased from 64.8 ± 5.11 to 62.82 ± 6.16 D, the mean corneal resistance factor (CRT) increased from 5.67 to 8.42, and the total higher-order aberrations decreased from 1.80 to 1.16 |
| Implantation occurred in 7 eyes with six due to advanced keratoconus and clear cornea and one with advanced post-Lasik ectasia followed for 12 months |
| Combined Platelet Rich Plasma and Amniotic membrane in the treatment of Perforated Corneal Ulcer Abdelghany et al. (2022)
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This is a case series of 10 patients that were diagnosed with corneal perforation and underwent emergency surgical procedure for repair through implantation of synthetic amniotic membrane with platelet-rich plasma clot under it with application of platelet-rich plasma eye drops - follow-up for 4 weeks |
Within the first 7 days all cases demonstrated formation of adequate intraocular pressure digitally, within, and complete sealing of the corneal perforation within the 4 weeks follow up period |
| Mild symptoms like foreign body sensation and lacrimation were reported only in the 1st postoperative week |
| Three of the patients underwent penetrating keratoplasty after 6 months with satisfactory visual outcomes |
| Recurrent pterygium treatment using mitomycin C, double amniotic membrane transplantation, and a large conjunctival flap Monden et al. (2018)
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The retrospective case series aimed to evaluate the clinical outcomes of surgery for recurrent pterygia using mitomycin C (MMC), double amniotic membrane transplantation (AMT), and a large conjunctival flap |
Mean follow-up period was 3.6 years |
| Study included 31 eyes in 31 patients with recurrent pterygia. All patients underwent pterygium excision, application of MMC, double AMT, and placement of a large conjunctival flap |
Mean preoperative and postoperative best-corrected visual acuities (logMAR conversion) were 0.23 and 0.13, respectively |
| Outcome was based on measured visual acuity, astigmatism, and recurrence |
Evidence of a significant difference between the mean preoperative (−3.85 D) and postoperative (−2.22 D) astigmatism |
| They defined recurrence as the presence of fibrovascular proliferative tissue crossing the limbus |
The recurrence rate was 3.2% (1/31 cases) |
| Surgical result of pterygium extended removal followed by fibrin glue-assisted amniotic membrane transplantation Liu et al. (2017)
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This prospective interventional cohort study enrolled 57 patients (58 eyes) who are undergoing pterygium extended removal followed by fibrin glue-assisted amniotic membrane transplantation and report the recurrence rate, complications, and cosmetic results of conjunctival wound edge and caruncle |
The cohort included 48 eyes with nasal pterygium, 5 eyes with temporal pterygium, and 5 eyes with double pterygium. 81.0% (n = 47), 0% (n = 0), 12% (n = 7), and 7% (n = 4) of eyes with Grades 1–4 recurrence, respectively |
| All patients received postoperative follow-up for at least 12 months |
Cosmetic results of conjunctival wound edge and caruncle in cases with nasal pterygium resulted in 59.3% (n = 32), 14.8% (n = 8), 9.3% (n = 5), 16.6% (n = 9), and 0% (n = 0) of eyes with Grades 1–5 morphology respectively |
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Overall, 5.1% (n = 3), 3.4% (n = 2), 3.4% (n = 2), 3.4% (n = 2), 1.7% (n = 1), 6.9% (n = 4), and 1.7% (n = 1) of patients suffered from postoperative pyogenic granuloma, transient diplopia, permanent motility restriction, steroid glaucoma, fat prolapse, sub amniotic membrane hemorrhage, and early detachment of amniotic membrane, respectively Litvin et al. (2021)
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| A study protocol for a multicenter randomized clinical trial evaluating the safety and feasibility of a bioengineered human allogeneic nanostructured anterior cornea in patients with advanced corneal trophic ulcers refractory to conventional treatment González-Andrades et al. (2017)
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This is a phase I-II, randomized, controlled, open-label clinical trial of ten Spanish hospitals to evaluate the safety, feasibility, clinical efficacy evidence of a bioengineered human allogeneic nanostructured lamellar anterior cornea in adults with severe trophic corneal ulcers refractory to conventional treatment or with sequelae of previous ulcers |
Results pending |
| Suture less cryopreserved amniotic membrane graft and wound healing after photorefractive keratectomy Vlasov et al. (2016)
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This prospective nonrandomized control trial aimed to evaluate the effect of sutureless cryopreserved amniotic membrane (Prokera) on corneal wound healing after photorefractive keratectomy (PRK) |
The amniotic membrane graft sped corneal reepithelialization 1 day after PRK but was not better than the bandage contact lens in hastening complete reepithelialization of the cornea. Visual outcomes, corneal clarity, and optical quality of the cornea were comparable between the amniotic membrane graft eyes and bandage contact lens eyes |
| Forty patients were enrolled |
| Amniotic Membrane Graft for Syntomathic Bullous Keratopathy (AMBUK) Pires et al. (1999)
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The study performed amniotic membrane transplantation at 5 centers on 50 consecutive eyes (50 patients) with symptomatic bullous keratopathy and poor visual potential |
The follow-up period of 33.8 weeks (3–96 weeks) after amniotic membrane transplantation revealed that 43 (90%) of 48 eyes with intolerable pain preoperatively became pain free postoperatively |
| From the 5 eyes that had residual pain, 3 received repeated amniotic membrane transplantation, 1 required a conjunctival flap for pain relief, and 1 had reduced pain |
| Epithelial defects in 45 (90%) of 50 eyes created and covered by amniotic membrane healed rapidly within 3 weeks |
