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Adapted Surgical Procedure for Argus II Retinal Implantation: Feasibility, Safety, Efficiency, and Postoperative Anatomic Findings.

Abstract

PURPOSE

To evaluate the feasibility, safety, and efficiency of an adapted surgical procedure used for postmarket Argus II implantations, so as to lower risks of postoperative hypotony or conjunctivoscleral erosion, and to describe the observed anatomic characteristics of the positioning of the implanted array.

DESIGN

Single-arm prospective multicenter clinical trial.

PARTICIPANTS

Eighteen consecutive patients with end-stage retinitis pigmentosa.

METHODS

To protect the site of insertion of the cable of the device, a scleral flap was systematically added to the standardized implantation procedure. It was associated with temporalis fascia autograft, so as to cover the episcleral-fixed electronics case. Intraoperative and postoperative data at day 1, weeks 1 and 2, and months 1, 3, and 6 were collected. Postoperative distance between electrode-array and retina was measured on spectral-domain optical coherence tomography images. Position of the array was evaluated on fundus images between months 1 and 6.

MAIN OUTCOME MEASURES

Feasibility of the modified surgical technique (time constraints, intraoperative complications), variations of intraocular pressure over time, postoperative ocular findings and adverse events, postoperative distance between the array and the retina, and rotation of the array between months 1 and 6 after implantation.

RESULTS

The adapted surgical technique was performed easily without associated specific complications. No cases of chronic hypotony or conjunctivoscleral erosion were reported. One serious device/procedure-related adverse event was recorded (sterile posterior uveitis), which resolved after vitrectomy. Postoperative distance between array and retina was variable: full apposition was achieved in 4 patients (22.22%), partial apposition observed in 9 patients (50.00%), and absence of strict apposition noted in 5 patients (27.78%, 4 of whom had posterior staphyloma). A statistically significant slight rotation of the array was observed between months 1 and 6 (P < 0.0001), occurring downwardly in 68.75% of cases.

CONCLUSIONS

The combined use of scleral flap and temporalis fascia autograft was easily achieved and effective in preventing hypotony and conjunctival erosion in our study. Postoperative distance between semirigid array and retinal surface was variable, and increased in the case of preoperative staphyloma. A slight rotation of the device occurred over time. Further studies based on larger samples are needed to confirm our findings and determine their functional consequences.

Links

Authors+Show Affiliations

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University of Bordeaux, Inserm, Bordeaux Population Health Research Center, team LEHA, UMR1219, Bordeaux, France; Department of Ophthalmology, Bordeaux University Hospital, Bordeaux, France. Electronic address: marie-noelle.delyfer@chu-bordeaux.fr.

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Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg, Strasbourg, France; Laboratoire de Bactériologie (EA-7290), Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg, Strasbourg, France.

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Department of Ophthalmology, Bordeaux University Hospital, Bordeaux, France.

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University of Bordeaux, Inserm, Bordeaux Population Health Research Center, team LEHA, UMR1219, Bordeaux, France.

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University of Bordeaux, Inserm, Bordeaux Population Health Research Center, team LEHA, UMR1219, Bordeaux, France; Department of Ophthalmology, Bordeaux University Hospital, Bordeaux, France.

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University of Bordeaux, Inserm, Bordeaux Population Health Research Center, team LEHA, UMR1219, Bordeaux, France.

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Sorbonne Universités, UPMC Univ Paris 06, INSERM U968, CNRS UMR 7210, Institut de la Vision, Paris, France; CHNO des Quinze-Vingts, DHU Sight Restore, INSERM-DGOS CIC 1423, Paris, France.

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Sorbonne Universités, UPMC Univ Paris 06, INSERM U968, CNRS UMR 7210, Institut de la Vision, Paris, France; CHNO des Quinze-Vingts, DHU Sight Restore, INSERM-DGOS CIC 1423, Paris, France.

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Centre de Référence pour les affections rares en génétique ophtalmologique, CARGO, Filière SENSGENE, Hôpitaux Universitaires de Strasbourg, Strasbourg, France.

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Centre de Référence pour les affections rares en génétique ophtalmologique, CARGO, Filière SENSGENE, Hôpitaux Universitaires de Strasbourg, Strasbourg, France; Medical Genetics Laboratory, INSERM U1112, Institute of Medical Genetics of Alsace, University of Strasbourg, Strasbourg Medical School, Strasbourg, France.

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Sorbonne Universités, UPMC Univ Paris 06, INSERM U968, CNRS UMR 7210, Institut de la Vision, Paris, France; CHNO des Quinze-Vingts, DHU Sight Restore, INSERM-DGOS CIC 1423, Paris, France; Fondation Ophtalmologique Rothschild, Paris, France; Department of Ophthalmology, The University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.

Sorbonne Universités, UPMC Univ Paris 06, INSERM U968, CNRS UMR 7210, Institut de la Vision, Paris, France; CHNO des Quinze-Vingts, DHU Sight Restore, INSERM-DGOS CIC 1423, Paris, France.

Source

Ophthalmology. Retina 2:4 2018 Apr pg 276-287

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31047236

Citation

Delyfer, Marie-Noëlle, et al. "Adapted Surgical Procedure for Argus II Retinal Implantation: Feasibility, Safety, Efficiency, and Postoperative Anatomic Findings." Ophthalmology. Retina, vol. 2, no. 4, 2018, pp. 276-287.
Delyfer MN, Gaucher D, Govare M, et al. Adapted Surgical Procedure for Argus II Retinal Implantation: Feasibility, Safety, Efficiency, and Postoperative Anatomic Findings. Ophthalmol Retina. 2018;2(4):276-287.
Delyfer, M. N., Gaucher, D., Govare, M., Cougnard-Grégoire, A., Korobelnik, J. F., Ajana, S., ... Barale, P. O. (2018). Adapted Surgical Procedure for Argus II Retinal Implantation: Feasibility, Safety, Efficiency, and Postoperative Anatomic Findings. Ophthalmology. Retina, 2(4), pp. 276-287. doi:10.1016/j.oret.2017.08.010.
Delyfer MN, et al. Adapted Surgical Procedure for Argus II Retinal Implantation: Feasibility, Safety, Efficiency, and Postoperative Anatomic Findings. Ophthalmol Retina. 2018;2(4):276-287. PubMed PMID: 31047236.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Adapted Surgical Procedure for Argus II Retinal Implantation: Feasibility, Safety, Efficiency, and Postoperative Anatomic Findings. AU - Delyfer,Marie-Noëlle, AU - Gaucher,David, AU - Govare,Marc, AU - Cougnard-Grégoire,Audrey, AU - Korobelnik,Jean-François, AU - Ajana,Soufiane, AU - Mohand-Saïd,Saddek, AU - Ayello-Scheer,Sarah, AU - Rezaiguia-Studer,Fouzia, AU - Dollfus,Hélène, AU - Sahel,José-Alain, AU - Barale,Pierre-Olivier, Y1 - 2017/10/26/ PY - 2017/07/27/received PY - 2017/08/01/revised PY - 2017/08/08/accepted PY - 2019/5/4/entrez SP - 276 EP - 287 JF - Ophthalmology. Retina JO - Ophthalmol Retina VL - 2 IS - 4 N2 - PURPOSE: To evaluate the feasibility, safety, and efficiency of an adapted surgical procedure used for postmarket Argus II implantations, so as to lower risks of postoperative hypotony or conjunctivoscleral erosion, and to describe the observed anatomic characteristics of the positioning of the implanted array. DESIGN: Single-arm prospective multicenter clinical trial. PARTICIPANTS: Eighteen consecutive patients with end-stage retinitis pigmentosa. METHODS: To protect the site of insertion of the cable of the device, a scleral flap was systematically added to the standardized implantation procedure. It was associated with temporalis fascia autograft, so as to cover the episcleral-fixed electronics case. Intraoperative and postoperative data at day 1, weeks 1 and 2, and months 1, 3, and 6 were collected. Postoperative distance between electrode-array and retina was measured on spectral-domain optical coherence tomography images. Position of the array was evaluated on fundus images between months 1 and 6. MAIN OUTCOME MEASURES: Feasibility of the modified surgical technique (time constraints, intraoperative complications), variations of intraocular pressure over time, postoperative ocular findings and adverse events, postoperative distance between the array and the retina, and rotation of the array between months 1 and 6 after implantation. RESULTS: The adapted surgical technique was performed easily without associated specific complications. No cases of chronic hypotony or conjunctivoscleral erosion were reported. One serious device/procedure-related adverse event was recorded (sterile posterior uveitis), which resolved after vitrectomy. Postoperative distance between array and retina was variable: full apposition was achieved in 4 patients (22.22%), partial apposition observed in 9 patients (50.00%), and absence of strict apposition noted in 5 patients (27.78%, 4 of whom had posterior staphyloma). A statistically significant slight rotation of the array was observed between months 1 and 6 (P < 0.0001), occurring downwardly in 68.75% of cases. CONCLUSIONS: The combined use of scleral flap and temporalis fascia autograft was easily achieved and effective in preventing hypotony and conjunctival erosion in our study. Postoperative distance between semirigid array and retinal surface was variable, and increased in the case of preoperative staphyloma. A slight rotation of the device occurred over time. Further studies based on larger samples are needed to confirm our findings and determine their functional consequences. SN - 2468-7219 UR - https://www.unboundmedicine.com/medline/citation/31047236/Adapted_Surgical_Procedure_for_Argus_II_Retinal_Implantation:_Feasibility,_Safety,_Efficiency,_and_Postoperative_Anatomic_Findings DB - PRIME DP - Unbound Medicine ER -