OSDI Outcomes Based on Patient Demographic and Wear Patterns in Prosthetic Replacement of the Ocular Surface Ecosystem

Figures & data

Figure 1 Illustration and optic section view of PROSE device on eye.

Notes: Slit lamp photographs of a PROSE device (BostonSight, Needham, MA, USA) on an eye with history of penetrating keratoplasty in diffuse white light (A) and optic section (B).

Table 1 Analysis of OSDI Outcomes with PROSE Wear, Based on Condition

Condition(s)	n	Baseline OSDI, Mean ±SD	Final OSDI, Mean ±SD (Median, IQR)	OSDI Reduction, Mean ±SD	p-value	OSDI Reduction (%), Mean ±SD (%)
KCS (excludes oGVHD)	27	64.4±21.2	27.7±16.1 (27.1, 16.7–36.5)	36.8±22.9	<0.01	55.6±28.6
Corneal ectasia	16	41.9±23.2	17.3±13.8 (13.5, 8.3–25.5)	24.6±18.5	<0.01	52.4±27.5
Corneal ectasia + KCS (excludes oGVHD)	9	53.2±19.6	23.6±14.8 (25.0, 16.7–27.1)	29.6±17.5	<0.01	55.6±24.7
Corneal scar/opacity	8	46.6±17.2	21.5±12.4 (22.6, 14.6–30.2)	25.1±10.6	<0.01	56.3±23.2
Other^a	8	50.8±25.4	25.0±18.6 (18.8, 13.0–37.5)	25.8±21.8	0.02	42.6±29.0
Limbal stem cell deficiency	7	59.8±18.2	27.6±19.5 (25.0, 12.2–44.8)	32.2±15.5	0.02	56.0±31.3
SJS/TENS^c	4	72.4±20.3	41.2±12.6 (39.6, 36.0–44.8)	31.3±27.8	–	35.0±38.7
Exposure keratopathy^c	3	53.7±5.6	18.1±9.7 (14.6, 11.5–23.0)	35.7±15.0	–	64.1±23.2
FK^c	3	82.4±7.8	33.3±16.4 (25.0, 21.9–40.6)	49.1±23.0	–	57.8±23.6
Atopic keratoconjunctivitis^c	2	35.4±6.3	13.3±4.9 (13.3, 10.8–15.7)	22.2±1.3	–	63.9±7.5
Corneal neuralgia^c	2	89.6±10.4	32.7±2.7 (32.7, 31.4–34.1)	56.9±7.7	–	63.3±1.2
Neurotrophic keratopathy^c	2	54.2±4.1	31.3±2.1 (31.3, 30.2–32.3)	22.9±6.3	–	41.7±8.3
oGVHD + KCS^c	2	66.9±14.4	21.9±3.1 (21.9, 20.3–23.4)	45.0±11.3	–	66.8±2.5
Pathological myopia^b,c	1	50.0	33.3	16.7	–	33.3
Persistent epithelial defect^b,c (PED)	1	75.0	50.0	25.0	–	33.3
Post-PK^b,c	1	29.2	8.3	20.9	–	71.4

Notes: ^aOther conditions included blepharitis, meibomian gland dysfunction, Salzmann’s nodular degeneration, ocular rosacea, chronic progressive external ophthalmoplegia, anterior basement membrane dystrophy, granular corneal dystrophy, myasthenia gravis, and high myopia. ^bAdditional statistical analysis (standard deviation, median, IQR) are not provided for categories containing one subject. ^cInadequate sample size to assess non-parametric paired results via Wilcoxon signed-rank test.

Abbreviations: oGVHD, ocular graft-vs-host disease; KCS, keratoconjunctivitis sicca; FK, filamentary keratitis; SJS/TENS, Stevens–Johnson Syndrome/toxic epidermal necrolysis syndrome; post-PK, postpenetrating keratoplasty.

Table 2 Analysis of the Average Response Scores to the OSDI Survey^a, by Question, at Follow-up

Question	n (43)	Baseline, Mean ±SD	Follow-Up, Mean ±SD	Change, Mean ±SD	p-value
1. Light sensitivity	43	2.60±1.47	1.25±1.43	−1.35±1.60	<0.01
2. Gritty	42	1.88±1.69	0.62±0.85	−1.26±1.74	0.01
3. Painful/sore	42	1.57±1.27	0.55±0.74	−1.02±1.27	<0.01
4. Blurred vision	43	2.60±1.40	0.91±0.89	−1.69±1.61	<0.01
5. Poor vision	40	2.70±1.44	0.79±0.94	−1.91±1.73	<0.01
6. Reading	43	2.51±1.49	1.16±1.33	−1.35±1.78	<0.01
7. Driving at night	42	2.88±1.49	1.14±1.54	−1.74±1.52	<0.01
8. Computer/ATM	42	2.48±1.56	0.81±1.15	−1.67±1.59	<0.01
9. Watching television	42	1.76±1.60	0.81±1.17	−0.95±1.55	<0.01
10. Windy conditions	42	2.40±1.75	1.26±1.42	−1.14±1.98	0.02
11. Low humidity conditions	42	2.17±1.77	1.21±1.43	−0.96±1.87	0.02
12. Air conditioning	42	1.58±1.69	0.86±1.32	−0.72±1.83	<0.01

Notes: ^aAnswers for each question on the OSDI survey is based on a 0–4 scale, with 0=none of the time, 1=some of the time, 2=half of the time, 3=most of the time, and 4=all the time. If a question is not applicable, a patient can elect to skip it. This table shows the number of patients which answered each question, the average baseline response score, the average follow-up OSDI survey score, and the change between baseline and follow-up.

Table 3 Comparison of OSDI Outcomes Between PROSE Treatment vs Other Therapies for the Treatment of Keratoconjunctivitis Sicca, or Dry Eye Disease

Study	Study Design	Treatment	OSDI Baseline Pretreatment (Mean)	OSDI Outcome Posttreatment (Mean)	p-value	OSDI Improvement (%) with Treatment (Mean)
Current^a	Retrospective	PROSE	64.4	27.7	<0.001	55.6
Yilmaz 2017^Citation39	Prospective, crossover controlled	Autologous serum tears	32.3	19.8	<0.001	48.4
Latifi 2020^Citation40	Prospective, non-controlled	Punctal occlusion	58.6	45.4	0.005	22.5
Yüksel 2009^Citation41	Prospective, non-controlled	Topical cyclosporine	30.0	21.3	0.00	29.0
Sheppard 2014^Citation42	Prospective, control	Loteprednol and cyclosporine	30.8	20.3	≤0.05	34.1
Finis 2014^Citation43	Prospective, randomized, crossover	Lipiflow	46.2	34.6	0.029	25.1

Note: ^aPROSE treatment outcomes in this study for all subjects with preexisting diagnosis of KCS.

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