Dataset Information

Long-term Follow-up of Patients With Retinitis Pigmentosa Receiving Intraocular Ciliary Neurotrophic Factor Implants.

ABSTRACT: To evaluate the long-term efficacy of ciliary neurotrophic factor delivered via an intraocular encapsulated cell implant for the treatment of retinitis pigmentosa.Long-term follow-up of a multicenter, sham-controlled study.Thirty-six patients at 3 CNTF4 sites were randomly assigned to receive a high- or low-dose implant in 1 eye and sham surgery in the fellow eye. The primary endpoint (change in visual field sensitivity at 12 months) had been reported previously. Here we measure long-term visual acuity, visual field, and optical coherence tomography (OCT) outcomes in 24 patients either retaining or explanting the device at 24 months relative to sham-treated eyes.Eyes retaining the implant showed significantly greater visual field loss from baseline than either explanted eyes or sham eyes through 42 months. By 60 months and continuing through 96 months, visual field loss was comparable among sham-treated eyes, eyes retaining the implant, and explanted eyes, as was visual acuity and OCT macular volume.Over the short term, ciliary neurotrophic factor released continuously from an intravitreal implant led to loss of total visual field sensitivity that was greater than the natural progression in the sham-treated eye. This additional loss of sensitivity related to the active implant was reversible when the implant was removed. Over the long term (60-96 months), there was no evidence of efficacy for visual acuity, visual field sensitivity, or OCT measures of retinal structure.

SUBMITTER: Birch DG

PROVIDER: S-EPMC5056139 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature

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Long-term Follow-up of Patients With Retinitis Pigmentosa Receiving Intraocular Ciliary Neurotrophic Factor Implants.

Birch David G DG Bennett Lea D LD Duncan Jacque L JL Weleber Richard G RG Pennesi Mark E ME

American journal of ophthalmology 20160725

<h4>Purpose</h4>To evaluate the long-term efficacy of ciliary neurotrophic factor delivered via an intraocular encapsulated cell implant for the treatment of retinitis pigmentosa.<h4>Design</h4>Long-term follow-up of a multicenter, sham-controlled study.<h4>Methods</h4>Thirty-six patients at 3 CNTF4 sites were randomly assigned to receive a high- or low-dose implant in 1 eye and sham surgery in the fellow eye. The primary endpoint (change in visual field sensitivity at 12 months) had been report ...[more]

PMID: 27457255

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Project description:BackgroundImplantation of a single-piece-acrylic intraocular lens (SPA-IOL) in the ciliary sulcus during phacoemulsification complicated with posterior capsule tear (PCT) may be associated with severe complications. The purpose of this study was to report the efficacy and safety of sulcus implantation of a SPA-IOL, designed for both in-the-bag and sulcus positioning.MethodsA prospective cross-sectional study including 12 patients, who underwent phacoemulsification with PCT and sulcus implantation of SPA-IOL designed for both in-the-bag and sulcus positioning (Seelens AF, Hanita, Israel) between January 2009 and March 2012 (follow-up 12-37 months). Preoperatively corrected distance visual acuity (CDVA), subjective refraction and intraocular pressure (IOP) were recorded. Postoperative evaluation included anamnesis for IOL edge symptoms and transient visual obscurations (TVO) along with CDVA, subjective refraction IOP, anterior segment biomicroscopy, gonioscopy, assessment of IOL centration, fundus biomicroscopy and spectral-domain optical coherence tomography of the macula.ResultsPreoperatively, mean CDVA was 0.84 ± 0.60 LogMAR (Counting Finger-20/33) improving to 0.18 ± 0.13 LogMAR (20/40-20/20) at last examination (p = 0.004), as all the patients gained better CDVA. Mean preoperative spherical equivalent was -0.2 ± 2.5 Diopter (D) (-4.0D to +5.4D) reaching -1.9 ± 0.9 (-4.0D to -0.6D) at last examination (p = 0.12). Mean preoperative refractive astigmatism magnitude was 1.0 ± 0.6D (0.3D to 2.3D) changing to 1.1 ± 1.0D (0.0D to 3.0D) at last examination (p = 0.88). Mean preoperative IOP was 14.7 ± 3.2 mmHg (11-23 mmHg) without medications reaching 15.9 ± 3.3 mmHg (10-21 mmHg) at last follow up (p = 0.21). Postoperatively one patient required two medications for IOP control in his study and contralateral eyes. None of the patients had symptoms of IOL edge or TVO. There were no intraocular hemorrhages, inflammatory reactions, or pigment dispersion and the IOLs were well centered in all cases. Central foveal thickness was 280 ± 33 ?m (193-310 ?m).ConclusionsAppropriately designed SPA-IOL may be implanted in the ciliary sulcus during phacoemulsification with PCT rather than switching to another backup IOL demanding wound enlargement.

Project description:To determine the rate of progression and optimal follow-up time in patients with advanced-stage retinitis pigmentosa (RP) comparing the use of fundus autofluorescence imaging and spectral-domain optical coherence tomography.Retrospective analysis of progression rate.Longitudinal imaging follow-up in 71 patients with retinitis pigmentosa was studied using the main outcome measurements of hyperautofluoresent ring horizontal diameter and vertical diameter along with ellipsoid zone line width from spectral-domain optical coherence tomography. Test-retest reliability and the rate of progression were calculated. The interaction between the progression rates was tested for sex, age, mode of inheritance, and baseline measurement size. Symmetry of left and right eye progression rate was also tested.Significant progression was observed in >75% of patients during the 2-year mean follow-up. The mean annual progression rates of ellipsoid zone line and hyperautofluorescent ring horizontal diameter and vertical diameter were 0.45 degree (4.9%), 0.51 degree (4.1%), and 0.42 degree (4.0%), respectively. The ellipsoid zone line width and hyperautofluorescent ring horizontal diameter and vertical diameter had low test-retest variabilities of 8.9%, 9.5%, and 9.6%, respectively. This study is the first to demonstrate asymmetrical structural progression rate between right and left eye, which was found in 19% of patients. The rate of progression was significantly slower as the disease approached the fovea, supporting the theory that RP progresses in an exponential fashion. No significant interaction between progression rate and patient age, sex, or mode of inheritance was observed.Fundus autofluorescence and optical coherence tomography detect progression in patients with RP reliably and with strong correlation. These parameters may be useful alongside functional assessments as the outcome measurements for future therapeutic trials. Follow-up at 1-year intervals should be adequate to efficiently detect progression.

Dataset Information

Long-term Follow-up of Patients With Retinitis Pigmentosa Receiving Intraocular Ciliary Neurotrophic Factor Implants.

Publications

Long-term Follow-up of Patients With Retinitis Pigmentosa Receiving Intraocular Ciliary Neurotrophic Factor Implants.

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