We searched PubMed and EMBASE from inception to October 15, 2025, for studies reporting ophthalmic findings in Danon disease. The full search strategy is provided in the Supplementary Materials. We excluded non-English studies and those without individual-level ophthalmic data. We removed duplicates and screened reference lists of eligible studies for additional articles.

We extracted data on study design, patient demographics, LAMP2 pathogenic variants, ophthalmic findings, imaging results, and systemic features. Sex was defined according to the original reports and interpreted as biological sex (male or female). Gender was not separately reported in the included studies and could not be evaluated independently. When summarizing prior studies, we used the terminology provided by the original authors. When images were available, we reviewed them directly rather than relying on authors’ interpretations. When images were not available, we relied on the authors’ descriptions. We extracted vague or inconsistent terminology verbatim and placed it in quotation marks. Two reviewers (ME, GS) independently performed study selection and data extraction, resolving discrepancies by discussion to reach consensus.

Primary outcomes were the prevalence and pattern of retinal and macular abnormalities identified on multimodal imaging, including fundus examination, OCT, FAF, and ERG. Secondary outcomes included best-corrected visual acuity (BCVA), visual field characteristics, refractive error, and anterior segment findings such as lens opacities or corneal changes. Additional analyses assessed whether ocular findings preceded systemic disease, age and sex-related differences, and genotype–phenotype associations.

The overall strength of evidence was limited by the predominance of case reports and small case series, leading to potential selection and reporting bias, inconsistent terminology, and heterogeneous imaging methods. Longitudinal data were scarce, and systemic or pharmacologic confounders were incompletely described. Because formal comparative or quantitative analyses were not possible, the certainty of evidence was qualitatively described rather than formally graded, and no GRADE assessment was performed.

We assessed risk-of-bias using the Joanna Briggs Institute critical appraisal checklists for case reports, case series, and retrospective cohorts. Each study was evaluated for demographic reporting, clarity of ophthalmic and systemic findings, image availability, and follow-up documentation.

We performed descriptive analyses using SPSS Statistics version 29 (IBM Corp). Continuous variables were summarized as medians with IQRs, and categorical variables as counts and percentages.

A systematic search of PubMed and EMBASE identified 34 studies reporting ophthalmic findings in Danon disease ( Figure 1 ). ^{,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,}

PRISMA 2020 flow diagram of study selection. The figure illustrates the literature search process to identify studies of patients with Danon disease exhibiting ophthalmic manifestations. A total of 607 studies were identified from databases (PubMed, EMBASE) and citation searching. After removing duplicates, 507 studies were screened, resulting in 84 assessed for eligibility. A total of 50 studies were excluded based on various criteria, leading to 34 studies included in the review, with 15 focusing primarily on ophthalmic manifestations and 19 not primarily focused on them.

Fifteen studies (44%) focused primarily on ophthalmic features, and 19 (56%) reported them as secondary observations. Of the 34 studies, 25 (74%) were case reports, 8 (24%) were case series, and 1 (3%) was a retrospective cohort. All quantitative findings reported below reflect the distribution of features among published cases with ophthalmic involvement and should be interpreted as descriptive rather than as estimates of population-level prevalence.

Table 1 summarizes the descriptive characteristics of the cohort, which included 70 patients (35 male, 35 female), with ages ranging from 6 to 81 years (median 27; IQR 26). Most patients (66/70, 94%) had confirmed diagnosis with genetic testing, and variant-level information was specified in 50. Across cases with specified molecular data, 27 distinct LAMP2 variants were reported, and most were truncating (17/27, 63%). Among the 50 cases with specified variants, exon involvement was most frequent in exon 8 (11/50), exon 3 (8/50), and exon 9 (7/50) ( Figure 2 ). Reported LAMP2 variants, variant classes, author-assigned ACMG/AMP criteria, classifications, and associated severe ocular and systemic phenotypes are summarized in Supplemental Table S1.

Distribution of reported LAMP2 variants associated with ophthalmic findings. (A) Schematic representation of the LAMP2 gene and splice isoforms. Exons 1 to 9 and alternative terminal exon usage (9A, 9B, 9C) are shown. Numbers below each exon indicate the number of reported variants associated with ophthalmic findings. Exon structure is shown schematically and is not drawn to genomic scale. (B) Schematic representation of the LAMP2 protein (410 amino acids) with exon–domain mapping. Exons 1 to 8 and part of exon 9 encode the shared luminal domain, whereas the remaining exon 9 sequence encodes the transmembrane (TM) region and isoform-specific cytoplasmic tail. Lollipop markers indicate distinct reported variants associated with ophthalmic findings. Colors denote variant class (truncating, missense, splice/splice-altering, and in-frame deletion). Detailed variant-level information is provided in Supplemental Table S1. Created in https://BioRender.com .

Ophthalmic findings were the first or only manifestation of Danon disease in 11 of 70 patients (16%; 4 males, 7 females). In seven, retinal changes appeared years before systemic disease was recognized. In four patients, all female carriers or mosaics, ocular abnormalities remained the only finding during follow-up. In two cases, the ophthalmic presentation prompted cardiac or genetic testing, leading to the diagnosis of Danon disease. Visual symptoms, most often blurry vision, were reported in 30/70 (43%). Among patients with quantifiable better-eye BCVA ( n = 42), the median was 0.00 logMAR (IQR 0.20): 20/42 (48%) had normal acuity (0.00 logMAR), 12/42 (29%) had mild reduction in visual acuity (0.10-0.30 logMAR), 7/42 (17%) had moderate reduction (0.40-1.00 logMAR), and 3/42 (7%) had severe reduction (>1.00 logMAR).

Nearly all patients had systemic involvement, most commonly hypertrophic cardiomyopathy (48/70, 69%), and 28/70 (40%) required heart transplantation. Arrhythmias (27/70, 39%), skeletal myopathy (23/70, 33%), and Wolff–Parkinson–White syndrome (17/70, 24%) were frequent.

Table 2 summarizes the ophthalmic findings. Retinal pigmentary changes were reported in 55/68 published cases (81%), most often as midperipheral or peripheral salt-and-pepper mottling (41/68, 60%). Near-complete pigment loss was seen in 7/68 (10%; 5 males, 2 females). Macular involvement was present in 43/68 (62%), usually as nonspecific RPE abnormalities (27/68, 40%). Clinically significant maculopathy, including macular atrophy, bull’s-eye maculopathy, or cystoid macular edema, was reported in 9/68 (13%; 6 males, 3 females).

OCT of the macula was available for 33/70 (47%), and 31/33 (94%) showed abnormalities. The most consistent findings were RPE and ellipsoid zone (EZ) disruption or thinning (28/33, 85%), external outer nuclear layer (ONL) hyperreflectivity (20/33, 61%), and drusenoid deposits (9/33, 27%). FAF was performed in 28/70 (40%) and revealed a mottled pattern in 24/28 (86%) and hyperautofluorescent foci in 12/28 (43%). ERG was available in 24/70 patients (34%), including 9 males and 15 females; nonspecific rod–cone dysfunction was reported in 7/9 males (78%) and 7/15 females (47%), although the small numbers and heterogeneous testing preclude inference of sex-based differences.

Myopia was reported in 11/70 (16%), including high myopia in 6/70 (9%). Lens abnormalities, such as white dots and cortical opacities, were observed in 9/70 (13%) and were not visually significant. The corneal endothelium was specifically assessed in three patients, all with normal findings.

Tables 3 and 4 provide detailed individual-level ophthalmic and systemic data. Table 5 presents the risk-of-bias assessment (Joanna Briggs Institute), highlighting frequent issues in ophthalmic reporting, such as vague terminology and incomplete documentation, particularly in studies not primarily focused on ophthalmic findings.

TABLE 3

Ophthalmic and Nonophthalmic Manifestations in Danon Disease: Insights From Studies With a Primary Focus on Ophthalmic Examination (15 Studies, 42 Patients)

Study	P	Sex	Age	Mutation	Ophthalmic Manifestations
Prall et al	1	F	–	Frameshift mutation (codon 361 in exon 8)	Fundus: peripheral pigmentary changes; ERG: prolonged implicit time; VF: enlarged blind spot, possible inferior arcuate.
	2	F	–		Lens: two white dots, cortical change; Fundus: peripheral pigmentary changes; ERG: increased latency of photopic white 0-decibel single flash.
	3	F	–		Lens changes; fundus: peripheral pigmentary changes; ERG: slight increased implicit times (photopic and scotopic).
	4	F	–		Fundus: peripheral pigmentary changes.
	5	M	–		BCVA: 20/60, 20/40; fundus: blonde fundi with near complete loss of pigment.
	6	M	–		BCVA: 20/30, 20/25; fundus: blonde fundi with near complete loss of pigment.
					Nonophthalmic findings: WPW in two females (unclear which one), HT for HCM in both males.
Schorderet	1	M	14	c.605C > G in exon 4 (p. Ser157X)	BCVA: 20/30 (OU); fundus: bilateral RPE hypopigmentation in macula, peripheral salt-and-pepper changes; FA: mottled RPE (macula and periphery); ERG: slightly abnormal scotopic full-field, moderately abnormal photopic full-field (symmetric); VF: slight, diffuse decreased sensitivity. Nonophthalmic findings: CM and arrhythmias several years after the eye exam. Ophthalmic abnormalities preceded systemic manifestations. Familial LAMP2 variant known.
	2	M	17		BCVA: 20/25 (OU); fundus: peripheral annular salt-and-pepper changes; FA: paramacular and peripheral mottled RPE; ERG: slightly abnormal scotopic full field (significant interocular asymmetry), slightly abnormal photopic full field (symmetric); VF: slight, diffuse decreased sensitivity. Nonophthalmic findings: CM and arrhythmias several years after the eye exam. Ophthalmic findings were the first indicators of DD. Familial LAMP2 variant known.
	3	F	53		Fundus: peripheral salt-and-pepper changes with marked chorioretinal atrophy nasally in both eyes; FA: mottled RPE (macula); ERG: slightly abnormal scotopic full field (asymmetric, OS > OD), slightly abnormal photopic full field; multifocal ERG: significant interocular asymmetry with lower amplitudes in the left eye; VF: peripheral sensitivity loss (OS > OD). Nonophthalmic findings: Ophthalmic findings were the only findings of DD. Familial LAMP2 variant known.
Mack	1	M	37	Dx with muscle biopsy	BCVA: 20/30, 20/200; fundus: macular edema (OS > OD), midperipheral pigmentary changes with near-complete RPE loss, highly myopic without posterior staphyloma; OCT: asymmetric macular cysts with patchy outer retinal atrophy; ERG: nonspecific abnormalities with reduced scotopic responses and normal photopic amplitude but increased implicit time; VF: bilateral central scotoma; patient refused FA. Macular edema unchanged after 18 wk despite topical dorzolamide 2% and oral acetazolamide. Nonophthalmic findings: HT for dilated CM at 20, myopathy, kidney lymphoma.
Thiadens et al	1	M	69	c.1150G > C in exon 9B (p.Gly384Arg in splice variant B)	Visual decline since 49; BCVA decreased to hand motion (OU); fundus/FA: bull’s eye maculopathy with decreased pigment in macular region; OCT: thinning of the outer segments and RPE in the macula; ERG: severely reduced cone responses (symmetric) and rod responses (asymmetric). Nonophthalmic findings: muscle weakness at 64 (quickly progressed to wheelchair dependency). Danon disease diagnosed subsequently. Ophthalmic findings preceded systemic manifestations and diagnosis.
	2	M	64		Visual decline since 30; BCVA decreased to 20/400 (OU); fundus: bull’s eye maculopathy and peripheral salt-and-pepper changes; OCT: thin photoreceptor layer, RPE thinning; ERG: cone responses more severely reduced than rod responses; VF: central scotoma and reduced peripheral sensitivity. Nonophthalmic findings: HCM, muscle weakness (wheelchair dependency by 40).
Thompson et al	1	F	6	c.294G > A in exon 3 (p. Trp98X)	BCVA: 20/20 (OU) for P1 and P4, 20/25 (OU) for P2, 20/20 OD and 20/40 OS for P3; Fundus: diffuse, streaky peripheral pigmentary changes (more pronounced in 2, 3); OCT: drusenoid deposits and RPE irregularity with EZ attenuation in P3, and RPE/EZ irregularity in P4; FAF: increased autofluorescence with age, starting as discrete white dots around the superior temporal arcade and becoming confluent in P3, with scattered dark spots; Arden ratio normal, but decreased amplitudes in both dark trough and light rise; ERG: normal, with very mild abnormalities in P2; VF: central field constriction and enlarged blind spots (no VF available for P1). Nonophthalmic findings: Systemic features not described. All had known LAMP2 mutation and confirmed Danon diagnosis; ophthalmic testing conducted for phenotypic characterization.
	2	F	24
	3	F	50
	4	M	13
Meinert et al	1	F	25	c.135dupA in exon 2 (p. Trp46Metfs*10)	Fundus: RPE clumping and atrophy (macula and periphery); OCT and OCT-A: deep retina plexus showed “irregular and less clearly visible vessels with more white dots”; FAF: irregular hypo- and hyper-autofluorescent changes secondary to RPE atrophy; FA: early small hyperfluorescent dots, less visible in late phases; ICG: numerous distinct hypofluorescent dots between the optic nerve and macula; ERG: normal; EOG: abnormal Arden ratio. More extensive atrophy at 5-y follow-up, with no decrease in BCVA. Nonophthalmic findings: HT at 22 for HCM, WPW, ICD.
Majer et al	1	F	37	Alu-mediated deletion of multiple exons	Fundus: salt-and-pepper changes; OCT: RPE/Bruch’s layer deposits and hyperreflective foci in the ONL; FAF: altered distribution sparing the fovea and parafovea; OCT-A: normal; VF: mild defects; decreased contrast sensitivity. Nonophthalmic findings: HT for dilated CM, mild ID.
Fukushima et al ,	1	M	50	Genetic dx: mutation not specified	Circular blurred vision around the central visual field in the right eye; fundus: normal; OCT: macular atrophy with EZ disruption and RPE thinning parafoveally; VF: paracentral scotoma (OD) and low sensitivity in the nasal field (OS); FAF: parafoveal hypofluorescence around the fovea (OD); ERG: reduced cone signal. Nonophthalmic findings : CM, pacemaker, retinal findings; late dx of DD at 47
Yang et al	1	F	21	c.123C > A in exon 2 (p. Cys41*)	Fundus: diffuse salt-and-pepper pigmentary changes in the peripheral retina; time-domain OCT: “normal”; FAF: diffusely scattered hyper- and hypofluorescent lesions, sparing the macula; FA: hyper- and hypofluorescence consistent with peripheral pigmentary lesions; ERG: normal. Twelve-year follow-up: spectral domain OCT: OPL granularity, ONL hyperreflective foci, RPE/EZ disruption. Retinal findings appeared before any cardiac manifestations. Nonophthalmic findings: No systemic manifestations at initial presentation. Developed atrial fibrillation and myocardial fibrosis 11 y later; ophthalmic abnormalities preceded systemic disease.
	2	F	51		Milder pigmentary changes than her daughter (P1); time domain OCT: “normal.” 12-y follow-up: no progression of symptoms; spectral domain OCT: OPL granularity, ONL thinning and hyperreflective foci; RPE/EZ disruption. Nonophthalmic findings: Arrhythmias present; Danon disease diagnosed only after daughter’s cardiac evaluation and subsequent LAMP2 testing.
Kousal et al	1	F	19	Genetic dx: mutation not specified	Fundus: peripheral pigmentary changes; OCT: OPL granularity, ONL hyperreflective foci, RPE/EZ disturbance; FAF: mottled pattern. Nonophthalmic findings: Cardiomyopathy (HT at 23 y).
	2	F	23		BCVA 20/32 (OU); fundus: peripheral pigmentary changes; OCT: OPL granularity, ONL hyperreflective foci, RPE/EZ disturbance, drusenoid deposits; FAF: mottled pattern with increased autofluorescent foci. Nonophthalmic findings: HT at 24.
	3	F	27		BCVA: 20/32, 20/20; nuclear white dots in lens; fundus: peripheral pigmentary changes; OCT: outer retinal deposits, ONL hyperreflective foci, OPL granularity, RPE/EZ disturbance; FAF: mottled pattern with hyperfluorescent foci. Nonophthalmic findings: HT at 27.
	4	F	28		Fundus: peripheral pigmentary changes; OCT: ONL hyperreflective foci, OPL granularity; FAF: mottled pattern. Nonophthalmic findings: Known LAMP2 mutation. No history of HT. Presence or absence of systemic findings not specified.
	5	F	39		BCVA: 20/32, 20/40; myopia, mild nuclear opacification; fundus: peripheral pigmentary changes, larger peripheral area of chorioretinal atrophy (OS); OCT: OPL granularity, ONL hyperreflective foci, drusenoid deposits, severe RPE/EZ disruption including fovea (OD), RPE/EZ disruption sparing fovea (OS); FAF: mottled with hyperfluorescent foci. Nonophthalmic findings: HT at 29 and 41; died at 41.
	6	F	41		BCVA: 20/50, 20/25; myopia, nuclear white dots; fundus: peripheral pigmentary changes; OCT: cystoid macular edema, RPE/EZ disruption (OD); OPL granularity, ONL hyperreflective foci, drusenoid deposits, RPE/EZ disturbance (OS); FAF: mottled pattern, hyperfluorescent foci. Nonophthalmic findings: HT at 21.
	7	F	47		BCVA: 20/40, 20/100; mild cortical cataract; fundus: peripheral pigmentary changes; OCT: OPL granularity, ONL hyperreflective foci, RPE/EZ disruption (OD), macular atrophy (OS); FAF: mottled pattern, hyperfluorescent foci. Nonophthalmic findings: HT at 28.
	8	F	45	Somatic mosaicism, exons 4 and 5 duplication	Fundus: few scattered yellow deposits (OS); OCT: OPL granularity; FAF: one hyperfluorescent dot (OD), few hypo- and hyperautofluorescent spots (OS); ERG: normal. Nonophthalmic findings: No systemic manifestations; LAMP2 mosaicism detected through familial genetic testing. Ophthalmic findings were the only manifestation of Danon disease.
	9	M	17	Genetic dx: mutation not specified	BCVA: 20/25 (OD), 20/32 (OS); high myopia; fundus: peripheral pigmentary changes and RPE clumping in fovea; OCT: OPL granularity, ONL hyperreflective foci, RPE/EZ disruption; FAF: normal. Nonophthalmic findings: HT at 20; died at 21.
	10	M	18		BCVA: 20/25 (OU). Fundus: midperipheral and posterior yellow dots and RPE clumping in fovea; OCT: OPL granularity, ONL hyperreflective foci, RPE/EZ disruption, drusenoid deposits; FAF: hyperfluorescent foci. Nonophthalmic findings: HT at 20.
	11	M	35		BCVA: 20/80, 20/200; myopic; fundus: peripheral pigmentary changes, patchy macular atrophy, and RPE clumping in the fovea; OCT: macular atrophy, OPL granularity, ONL hyperreflective foci, RPE/EZ disruption, drusenoid deposits; FAF: mottled pattern, hyperfluorescent foci, and hypofluorescent ring in the fovea. Nonophthalmic findings: HT at 28. Note: Except for the mosaic carrier, all patients had known LAMP2 variants and confirmed Danon diagnoses based on cardiomyopathy and/or histopathology; ophthalmic testing was performed for phenotypic characterization.
Hasegawa et al	1	F	26	Genetic dx: mutation not specified	Punctate cataract; fundus: peripheral salt-and-pepper changes; OCT: OPL granularity, ONL hyperreflective foci, RPE/EZ disruptions; FAF: multiple hyperfluorescent and hypofluorescent dots in the posterior pole, diffuse hypofluorescent pattern mainly inferonasal; ERG: normal; Adaptive optics: ambiguous macular cone mosaic pattern. Nonophthalmic findings: HCM (dilated phase), WPW.
O’Neil et al	1	F	45	Genetic dx: mutation not specified	OCT: subtle OPL granularity, disruptions of EZ; FAF: speckled pattern in pericentral and midperiphery; ERG: normal. Nonophthalmic findings: Asymptomatic carrier; LAMP2 mutation identified after her son’s Danon diagnosis. No cardiac involvement at ophthalmic evaluation.
	2	F	60	c.973dupC in exon 8 (p. Leu325Profs*25)	Blurring of central vision; BCVA: 20/40 and 20/70; significant cataracts; fundus: peripapillary atrophy, macular pigment mottling sparing the fovea, subtle peripheral pigmentary changes with visible choroidal vasculature; OCT: macular atrophy, OPL granularity, RPE/EZ disruptions; FAF: diffuse speckled hypofluorescence and lacunar hypofluorescence near the disc; ERG: reduced cone and rod amplitudes, severely depressed multifocal ERG; VF: moderately constricted with enlarged blind spots. Nonophthalmic findings: history of HT, ablations, and ICD implantation for recurrent arrhythmias.
Dao et al	1	F	24	Dx method not specified	Fundus: pigmentary changes, vascular tortuosity; OCT: “hyperreflective dots along the ELM”; en-face OCT: diffusely speckled appearance at the ELM level, OPL granularity; FAF: mottled pattern of hypo- and hyper-fluorescence. Nonophthalmic findings: HT for CM.
Narayan et al	1	F	54	c.925del in exon 7 (p. Ser309fs)	Worsening night vision difficulties over the past 3 y. Fundus: peripheral pigmentary changes; OCT: OPL granularity, ONL hyperreflective spots, RPE/EZ disruption; FAF: symmetric widespread speckled pattern; Mesopic microperimetry: slightly reduced sensitivity. Nonophthalmic findings: HT for dilated CM, stroke, partial deafness.
Emfietzoglou et al	1	F	25	Intron 6 donor splice site, c.864 + 1G > T in exon 6	Mild nighttime glare; BCVA: 20/20 OU; fundus: blonde fundus (blonde hair, fair complexion), peripheral “pepper”-like pigmentary changes; OCT: external ONL hyperreflectivity, ONL attenuation, OPL granularity with intact EZ and RPE; infrared imaging: RPE changes extending to midperiphery; multifocal and full-field ERG: normal. Three-year follow-up: stable. Systemic findings: defibrillator at 18 y, HT at 24 y.
	2	F	38	c.928G > A in exon 7 (p.Val310Ile)	Floaters and flashes; BCVA: 20/20 OU; fundus: blonde fundus, mild macular pigmentary changes, peripheral “pepper”-like pigmentary clumping; OCT: external ONL hyperreflectivity, drusenoid deposits, OPL granularity; FAF: multifocal, punctuate hyperautofluorescent lesions with a hypoautofluorescent halo, more pronounced temporally parafoveally, OD > OS. One-year follow-up: stable. Systemic findings: HT at 27 y.
	3	M	23	Genetic dx: mutation not specified	BCVA: 20/20 OU; high myopia; normal IOP; gonioscopy: deep angles with trace pigmentation; fundus: mild RPE changes; OCT of macula (tilted): normal foveal contour with external ONL hyperreflectivity, and OPL granularity. OCT of optic nerve: GCIPL thinning, optic nerve asymmetry. VF: superior nasal step (OD). Dx of glaucoma suspect, no therapy indicated. Eight-and 21-mo follow-up: stable. Systemic findings: HT.
	4	M	33	c.205_2018del (multiexon deletion; p.His69Ilefs*2)	Intermittent blurriness and photophobia; BCVA: 20/25, 20/60; fundus: macular atrophy with relative foveal preservation, circumferential RPE mottling, and mild midperipheral RPE irregularities (OU); OCT: foveal and parafoveal outer retinal atrophy with breakdown of the outer retinal bands and RPE disruption; FAF: parafoveal hypoautofluorescence with punctate hyperautofluorescence extending to the arcades and midperiphery (OD > OS); ERG: dysfunction cones > rods; Goldmann perimetry: central, paracentral scotomas (OD > OS); 2-y follow-up: BCVA decline to 20/60, 20/100 with progressive macular atrophy and expanding VF defects. Systemic findings: HT, defibrillator, skeletal myopathy, learning difficulties.
	5	F	7	Genetic dx: mutation not specified	BCVA: 20/25 (OD), 20/30 (OS); myopia, astigmatism; history of strabismus surgery; fundus: peripheral RPE mottling (OU); OCT: normal foveal contour with external ONL hyperreflectivity and OPL granularity; suboptimal image quality OS; FAF: hypoautofluorescent spots corresponding to pigmentary change; no atrophy; ERG: cone > rod dysfunction. Systemic findings: Raynaud’s phenomenon. Ophthalmic findings prompted LAMP2 testing, which led to diagnosis of Danon.

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