Ignite Creation Date:
2024-05-06 @ 2:11 PM
Last Modification Date:
2024-10-26 @ 1:26 PM
Study NCT ID:
NCT04234438
Status:
COMPLETED
Last Update Posted:
2020-01-23
First Post:
2020-01-16
Brief Title:
Management of Cystoid Macular Edema Secondary to Retinitis Pigmentosa Via Subliminal Micropulse Yellow Laser
Sponsor:
Ankara Universitesi Teknokent
Organization:
Ankara Universitesi Teknokent
Study Overview
Official Title:
Management of Cystoid Macular Edema Secondary to Retinitis Pigmentosa Via Subliminal Micropulse Yellow Laser
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SL-MPL
Brief Summary:
Purpose To investigate the effects of subliminal micropulse yellow laser application on central macular thickness and best corrected visual acuity in cystoid macular edema secondary to retinitis pigmentosa patients
Detailed Description:
Retinitis pigmentosa RP is a progressive photoreceptor and retinal pigment epithelial RPE degeneration that begins as a night vision loss resulting in narrowing of the visual field and legal blindness RP is a heterogeneous genetic disorder affecting 13000- 8000 people worldwide RP is the result of mutation in one of more than 260 genes These genes are responsible for the synthesis of peptides involved in the visual cycle These genes are also responsible for the synthesis of growth factors responsible for the conversion of glucose to adenosine triphosphate ATP or responsible for the removal of metabolic wastes
The incidence of cystoid macular edema CME in RP has been reported as between 10 - 50 There are several hypotheses about the pathogenesis of cystoid macular edema in RP The first hypothesis is explained by Müller cell hypertrophy and its paracrine effects Mutations in the retinal pigment epithelium disrupt the synthesis of some growth factors Stress caused by apoptosis in rod cells in the periphery leads to ectopic synaptogenesis of Müller cells in the central Müller cells undergo copensatory hypertrophy and synthesize excessive growth factors This paracrine effect provides protection of central vision Edema in a certain level is considered to be protective to photoreceptors and should not be treated But if edema is excessive and prolonged leads to a break in synaptic connections in the neural retina and an increase in neurodegeneration CME also deteriorates central visual quality in patients with impaired peripheral vision Treatment should be considered only if the edema is excessive and disrupts central vision According to our clinical experience when central macular thickness exceeds 500 microns central visual quality of the patient decreases and requires treatment
Other pathophysiological causes of CME in RP are explained by low grade inflammation and retinal autoantibodies In some genetic mutation types of RP such as the X-linked RPGR gene mutation vitritis lipofuscin deposits and inflammation are predominant Ciliopathy leads to inflammation and CME which increases photoreceptor loss rate Immediate treatment of inflammation-induced edema can slow disease progression Inflammatory edema appears as cystoid macular edema whereas compensatory edema due to Müller cell hypertrophy is seen as separeted intraretinal cysts Inflammatory edema responds well to carbonic anhydrase inhibitors while compensatory edema does not
The results of the treatment of CME in RP are controversial as the compensatory or inflammatory distinction is not made clearly Treatments such as grid laser photocoagulation oral acetazolamide topical carbonic anhydrase inhibitors intravitreal therapy with corticosteroids or anti-vascular endothelial growth factor agents and pars plana vitrectomy may be effective in some cases with CME secondary to RP Most of these treatments have either insufficient response or excessive side effects
To our knowledge so far we have not found a scientific publication about the use of micropulse yellow laser for treatment cystoid macular edema secondary to retinitis pigmentosa
Subliminal micropulse laser SL-MPL is a method developed to reduce the laser-induced thermal damage caused by conventional laser therapy for treatment some macular diseases In the micropulse mode laser is applied in short pulses thereby reducing the thermal energy generated in the target area The coagulation scars do not form with SL-MPL treatment Sublethally injured RPE cells induce an up- and down regulation of various growth factors GFs pigment epithelium-derived factor PEDF vascular endothelial growth factor VEGF inhibitors VEGF inducers permeability factors etc which restores the pathologic imbalance
The aim of this study was to investigate the effect of yellow 577 nm SL-MPL therapy on central macular thickness CMT and on best corrected visual acuity BCVA in patients with cystoid macular edema secondary to retinitis pigmentosa
The incidence of cystoid macular edema CME in RP has been reported as between 10 - 50 There are several hypotheses about the pathogenesis of cystoid macular edema in RP The first hypothesis is explained by Müller cell hypertrophy and its paracrine effects Mutations in the retinal pigment epithelium disrupt the synthesis of some growth factors Stress caused by apoptosis in rod cells in the periphery leads to ectopic synaptogenesis of Müller cells in the central Müller cells undergo copensatory hypertrophy and synthesize excessive growth factors This paracrine effect provides protection of central vision Edema in a certain level is considered to be protective to photoreceptors and should not be treated But if edema is excessive and prolonged leads to a break in synaptic connections in the neural retina and an increase in neurodegeneration CME also deteriorates central visual quality in patients with impaired peripheral vision Treatment should be considered only if the edema is excessive and disrupts central vision According to our clinical experience when central macular thickness exceeds 500 microns central visual quality of the patient decreases and requires treatment
Other pathophysiological causes of CME in RP are explained by low grade inflammation and retinal autoantibodies In some genetic mutation types of RP such as the X-linked RPGR gene mutation vitritis lipofuscin deposits and inflammation are predominant Ciliopathy leads to inflammation and CME which increases photoreceptor loss rate Immediate treatment of inflammation-induced edema can slow disease progression Inflammatory edema appears as cystoid macular edema whereas compensatory edema due to Müller cell hypertrophy is seen as separeted intraretinal cysts Inflammatory edema responds well to carbonic anhydrase inhibitors while compensatory edema does not
The results of the treatment of CME in RP are controversial as the compensatory or inflammatory distinction is not made clearly Treatments such as grid laser photocoagulation oral acetazolamide topical carbonic anhydrase inhibitors intravitreal therapy with corticosteroids or anti-vascular endothelial growth factor agents and pars plana vitrectomy may be effective in some cases with CME secondary to RP Most of these treatments have either insufficient response or excessive side effects
To our knowledge so far we have not found a scientific publication about the use of micropulse yellow laser for treatment cystoid macular edema secondary to retinitis pigmentosa
Subliminal micropulse laser SL-MPL is a method developed to reduce the laser-induced thermal damage caused by conventional laser therapy for treatment some macular diseases In the micropulse mode laser is applied in short pulses thereby reducing the thermal energy generated in the target area The coagulation scars do not form with SL-MPL treatment Sublethally injured RPE cells induce an up- and down regulation of various growth factors GFs pigment epithelium-derived factor PEDF vascular endothelial growth factor VEGF inhibitors VEGF inducers permeability factors etc which restores the pathologic imbalance
The aim of this study was to investigate the effect of yellow 577 nm SL-MPL therapy on central macular thickness CMT and on best corrected visual acuity BCVA in patients with cystoid macular edema secondary to retinitis pigmentosa
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None