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改良角膜假体装置(ORC-KPro)在终末期角膜盲患者中进行的2期(关键)使用的临床结果。

Clinical Outcomes of Stage 2 (Pivotal) Use of a Modified Keratoprosthesis Device (ORC-KPro) in Patients with End-stage Corneal Blindness.

作者信息

Rahmani Saeed, Karimian Farid, Hassanpour Kiana, Jafarinasab Mohammad-Reza, Feizi Sepehr, Safi Sare, Ali Javadi Mohammad

机构信息

Department of Optometry, School of Rehabilitation, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Ophthalmic Research Center, Research Institute for Ophthalmology and Vision Science, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

出版信息

J Ophthalmic Vis Res. 2024 Sep 16;19(3):297-305. doi: 10.18502/jovr.v19i3.13307. eCollection 2024 Jul-Sep.

DOI:10.18502/jovr.v19i3.13307
PMID:39359533
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11444000/
Abstract

PURPOSE

To investigate the short-term results and performance of a modified Boston keratoprosthesis device manufactured by the Ophthalmic Research Center (ORC-KPro) in patients with end-stage corneal blindness.

METHODS

This prospective interventional case series was conducted on patients with corneal blindness who were candidates for KPro. The inclusion criterion comprised patients with a best-corrected visual acuity (BCVA) of less than 20/200 in both eyes, in whom the main reason for vision loss was corneal pathology. The ORC-KPro was implanted using the method previously described for Boston KPro.

RESULTS

This study focused on 12 eyes of 12 patients with an average age of 45.9 16.8 (range, 19 to 70) years. Eleven patients were male. The KPro indication was corneal blindness due to chemical burns in nine patients (75%) and failure of multiple previous corneal grafts in three patients (25%). Anatomical success was achieved in all patients. The preoperative BCVA was light perception (LP) in 10 eyes and hand motion in 1 eye. Except for one patient who was diagnosed with grade C proliferative vitreoretinopathy during the surgery, the vision of all other patients (91.6%) improved after surgery. The retroprosthetic membrane (RPM) was formed in two eyes (18.1%) after six months. Of the 12 patients, 10 (83.3%) were under treatment with two antiglaucoma medications before surgery. The intraocular pressure of three eyes (25%) was estimated to be high by tactile palpation; however, it decreased in two eyes to the acceptable range. One patient underwent retinal surgery due to total retinal detachment, and two patients (16.7%) underwent vitrectomy due to endophthalmitis.

CONCLUSION

The current study showed that, in the short term, the use of ORC-KPro achieved favorable anatomical success in patients with corneal blindness. However, the functional success rate was limited by the low visual potential due to advanced glaucoma in most patients.

摘要

目的

研究眼科研究中心制造的改良波士顿人工角膜装置(ORC-KPro)在终末期角膜盲患者中的短期效果和性能。

方法

本前瞻性干预性病例系列研究针对适合植入KPro的角膜盲患者开展。纳入标准包括双眼最佳矫正视力(BCVA)低于20/200且视力丧失的主要原因是角膜病变的患者。ORC-KPro采用先前描述的用于波士顿KPro的方法植入。

结果

本研究聚焦于12例患者的12只眼,平均年龄为45.9±16.8岁(范围19至70岁)。11例为男性。KPro的适应证为9例(75%)患者因化学伤导致角膜盲,3例(25%)患者因多次先前角膜移植失败。所有患者均获得解剖学成功。术前10只眼的BCVA为光感(LP),1只眼为手动。除1例患者在手术期间被诊断为C级增殖性玻璃体视网膜病变外,所有其他患者(91.6%)术后视力均有改善。6个月后,2只眼(18.1%)形成了人工角膜后膜(RPM)。12例患者中,10例(83.3%)在手术前接受两种抗青光眼药物治疗。通过触诊估计3只眼(25%)的眼压较高;然而,其中2只眼的眼压降至可接受范围。1例患者因视网膜完全脱离接受了视网膜手术,2例患者(16.7%)因眼内炎接受了玻璃体切除术。

结论

当前研究表明,短期内,ORC-KPro在角膜盲患者中取得了良好的解剖学成功。然而,由于大多数患者存在晚期青光眼导致视觉潜力较低,功能成功率受到限制。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b593/11444000/781d576f99cc/jovr-19-297-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b593/11444000/4b53e697fd50/jovr-19-297-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b593/11444000/ef9f6cd29ec5/jovr-19-297-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b593/11444000/781d576f99cc/jovr-19-297-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b593/11444000/4b53e697fd50/jovr-19-297-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b593/11444000/ef9f6cd29ec5/jovr-19-297-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b593/11444000/781d576f99cc/jovr-19-297-g003.jpg

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The Boston Keratoprosthesis-The First 50 Years: Some Reminiscences.
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