Cohort study of global, psychological, and visual quality of life one year after evisceration/enucleation surgery: QOLAE 1 study

Abstract

Purpose:

To describe the evolution of health-related quality of life (HRQoL) 12 months after eye amputation surgery and to identify the factors influencing HRQoL.

Design:

A prospective cohort study was conducted.

Methods:

• Setting: A monocentric study was performed. • Patient Population: A total of 35 patients who had to undergo a surgical eye amputation were included and followed for a period of 12 months. • Intervention: Three standardized HRQoL questionnaires were filled at two time points: 3 months postoperatively (initial phase) and 12 months postoperatively (subsequent phase). The questionnaires were the following: The National Eye Institute Visual Functioning Questionnaire 25 (NEI VFQ-25), the Short Form-36 (SF-36), and the Perceived Stress Scale (PSS). • Main Outcome Measure: The variation in the quality of life as reflected in the NEI VFQ‐25 score compared at 3 months to 12 months after surgery.

Results:

No significant difference was observed in the multidimensional analysis scales of the HRQoL 12 months after eye amputation surgery. Regarding the VFQ-25 subscales, the peripheral visual field and the dependence on others were significantly improved at 12-month follow-up (P < 0.01). A multivariate analysis conducted at the 12-month follow-up revealed a significant association between a history of stroke and a decline in physical quality of life.

Conclusions:

The improvement and stabilization of HRQoL in patients who have undergone ocular amputation surgery are indicative of adaptative mechanisms. It would be beneficial to implement a tailored preparation program for patients with factors that may impact HRQoL prior to undergoing this surgical procedure.

Health-related quality of life (HRQoL) is defined as the health aspects of quality of life. It is generally considered to reflect the impact of disease and treatments on disability and daily functioning, as well as the impact of perceived health on an individual’s ability to lead a fulfilling life.[1] In the field of ophthalmology, eye amputation surgeries are primarily conducted with the objective of enhancing or maintaining HRQoL. The most common indication for these procedures is a painful eye that has lost its visual functionality.[2,3] While the primary intention is to alleviate pain, these surgeries also result in an improvement in the patient’s esthetic appearance.[4]

Despite advances in surgical techniques, orbital implant materials, and ocular prostheses, these surgeries are often perceived as “mutilating” by the public. In fact, these patients experience a significant esthetic change that is associated with an increased risk of anxiety, somatization, and depression.[5,6,7] It requires adaptation from the patient, resulting in significant changes in both personal and professional aspects of his life. These include family life, self-esteem, esthetic appearance, and professional activities such as reclassification and driving difficulties.[8,9] In a recent study, our research team observed an early decline in HRQoL in these patients across all domains, particularly in the domains of vision, mental health, and physical health.[10,11] It would be beneficial to describe the evolution of the multidimensional concept of HRQoL and to identify factors that lead to significant changes in HQoL after eye amputation surgery. This would allow the development of more personalized support interventions that would address the various dimensions of quality of life.

The objective of this study was to describe the evolution of HRQoL and its impact on visual function, general health, and perceived stress 12 months after eye amputation surgery and to identify factors influencing the different dimensions of HRQoL.

Methods

Study design

A prospective cohort study was conducted and was followed for 12 months after an eye amputation surgery. Evolution of global, psychological, and visual quality of life after an evisceration/enucleation surgery was based on a subset of the population from the previous QOLAE study, called QOLAE 1 study (Quality Of Life After Evisceration/Enucleation at 1 year).[11]

Study population

The patients over 18 years of age who had to undergo a surgical eye amputation by evisceration or enucleation, whatever the indication, were included.

The patients were not included if they were illiterate, had poor French language skills, or suffered from neurocognitive disorders that affected their ability to answer the questionnaires. A bilateral eye amputation surgery, the absence of prosthetic fitting during the 3-month and 12-month follow-up, and loss to follow-up were exclusion criteria.

Data collection

Prior to the eye amputation surgery, all patients underwent a comprehensive ophthalmologic examination during the preoperative visit, including a visual acuity measurement, a slit-lamp examination, and a fundus examination in both eyes. They were included in the study from the time of surgery and then followed for 12 months. All surgeries were performed under general anesthesia by the same orbitopalpebral experienced surgeon, and a porous polyethylene orbital implant was systematically placed. Two follow-up visits were included in the protocol: The first one early after surgery (at 3 months) and the second one later after surgery (at 12 months). At each visit, an examination of the orbital cavity of the operated eye was performed, and the patients were asked to complete three standardized HRQoL questionnaires. The intermediate and final prosthetic fittings were performed at 1 and 6 months, respectively.

The medical data were collected: Age, sex, WHO performance score,[12] standard of living (low, medium, or high defined by occupation and salary recorded by INSEE), marital status, parental status, place of residence, general medical history prior to the surgery, characteristics of the fellow eye, surgical indication, previous treatments of the operated eye, duration of visual loss and pain, degree of surgical urgency, surgical procedure, length of hospital stay, postoperative pain (Visual Analog Scale score > 4), and postoperative complications. At the 12-month visit, phantom vision and phantom pain were documented through medical interrogation.

The three standardized HRQoL questionnaires were completed in the presence of the clinician at the 3-month and 12-month visits. The French language validation questionnaires were: The National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25) employed for the purpose of assessing vision-related quality of life,[10] the Short Form-36 (SF-36) for the purpose of measuring the global quality of life,[13] and the Perceived Stress Scale-10 (PSS-10) for the purpose of evaluating the psychological state of the patients.[14] The composite scores were calculated as the average of all vision dimension scores for the NEI VFQ-25 and as a physical mean score (PCS = Physical Composite Score) and a mental mean score (MCS = Mental Composite Score) for the SF-36.[15]

Assessment of outcomes

The primary outcome was defined as the variation in the quality of life as reflected in the NEI VFQ‐25 score compared at 3 months to 12 months after surgery. The secondary endpoints included the scores of the PSS‐10 and of the SF‐36 compared at 3 months to 12 months after surgery.

Ethical approval

The study protocol follows the tenets of the Declaration of Helsinki and was approved by the local ethics committee. An informed consent was obtained before inclusion for each patient.

Statistical analysis

Descriptive statistics were applied to analyze numerical and nominal data, while inferential statistics assessed differences in scores from 3 to 12 months postsurgery. Correlations were made between scores and patient characteristics or confounders. Pearson’s correlation coefficient was used for continuous, normally distributed variables, with normality checked via the Shapiro–Wilk test and Q-Q plot. Spearman’s correlation was applied to ordinal or non-normally distributed variables. The Chi-square test evaluated categorical relationships, with Phi correlation for dichotomous variables. Student’s t-test was used for continuous, normally distributed variables, and Wilcoxon Mann–Whitney for non-normally distributed variables. Multiple linear regressions examined the relationships between risk factors and questionnaire scores to identify predictors of poor HRQoL. A P value under 0.05 was considered significant, and all analyses were performed using SPSS® Software version 25.0.0 from IBM, located in Chicago, Illinois, USA.

Results

A total of 38 patients were screened for eligibility at the preoperative visit. Among them, 35 patients were included in the study and underwent an eye amputation surgery between January 2021 and January 2023 at the Department of Ophthalmology of the University Hospital of Besançon (France). At 3 months, 33 patients completed the questionnaires, and 2 patients were excluded following their death. At 12 months, 28 patients completed the questionnaires, and 5 patients were excluded [Fig. 1].

Figure 1.

Flow chart of the study which shows the separate steps of the flow patient

Baseline demographic and ocular characteristics

A majority of men (57%) with a mean age of 67.2 ± 17.5 years were included. Ninety-one percents resided at home. Most patients were retired (62.9%). Of the total number of patients, 57.1% resided with a partner, while 28.6% were widowed and 14.3% were single. A total of 71.4% patients reported having children. Regarding the domain of addiction, 17.1% were identified as smokers. Concerning the general level of health of the cohort, the mean WHO score was 1.1 ± 1.7. Among the medical histories, less than half of the patients had a documented medical history. Most patients (42.9%) belonged to a medium socioeconomic class. In our study, ocular trauma was identified as the primary cause of eye amputation, accounting for 39% of cases [Supplementary material 1 ^{(400.1KB, tif)} ]. Forty-eight percents had suffered from phthisis bulbi, and 42.9% had a painful eye which had been operated on to relieve the pain. The mean duration of vision loss was 185.6 (±231.4) months. Emergency procedures were performed in 25.7% of cases. Prior to surgery, the vast majority of patients (68.6%) consulted with an oculo-prosthetist. The surgical procedure consisted of 85.7% of eviscerations and 14.3% of enucleation associated with a dermo-lipidic graft in 17.1% of cases [Supplementary material 2 ^{(406KB, tif)} ]. The implant size was 18 mm in most surgery (51.4%). The mean length of hospitalization was 3 ± 1.4 days with the objective of alleviating acute pain. An acute postoperative pain was experienced by 62.9% of patients. No acute postoperative complications were observed [Table 1].

Table 1.

Baseline demographic and ocular characteristics of the study population

Characteristics of the studied population	n=35
Age (years) mean (±SD)	67.2 ±17.5
Sex ratio (M/F)	20 (57.1%)
Lifestyle n (%)   -Home   -Assisted living facility for seniors	32 (91.4%) 3 (8.4%)
Marital status n (%)   -Married   -Widow   -Single	20 (57.1%) 10 (28.6%) 5 (14.3%)
Parental status: Children n (%)	25 (71.4%)
Pensioner n (%)	22 (62.9%)
WHO score mean (±SD)	1.1 ±1.7
Tobacco n (%)	6 (17.1%)
Medical history n (%)   -None   -High blood pressure   -Diabetes   -Neoplasm   -Hypothyroidism   -Depression   -Stroke   -Cardiac diseases	16 (57%) 13 (37.1%) 8 (22.9%) 5 (14.3%) 5 (14.3%) 5 (14.3%) 4 (11.4%) 6 (17.1%)
Socioeconomic level n (%)   -Low   -Medium   -High	13 (37.1%) 15 (42.9%) 7 (20%)
Amputated side (OS) n (%)	18 (51.4%)
BCVA of the contralateral eye (LogMar) mean (±SD)	0,5±0.5
Surgical indication n (%)   -Phthisis bulbi   -Pain   -Esthetic	17 (48.6%) 15 (42.9%) 6 (17.1%)
Duration of the loss of vision (months) mean (±SD)	185.6±231.4
Preoperative visit to the prosthetist n (%)	24 (68.6%)
Emergency surgery n (%)	9 (25.7%)
Size of the implant (mm) n (%)   -16 mm   -18 mm   -20 mm	4 (11.4%) 18 (51.4%) 13 (37.2%)
Duration of hospitalization (days) mean (±SD)	3±1.4
Acute postoperative pain n (%)	22 (62.9%)

SD=standard deviation, M/F=Male/Female, WHO=World Health Organisation, OS=left eye

Postoperative complications at 12-month follow-up

At the 12-month visit, distant postoperative complications were noted: Implant exposure (8.5%), scar necrosis (2.8%), conjunctival disruption (2.8%), phantom pain (17.1%), and phantom vision (25.7%). No infection, no granuloma, or socket syndrome was observed. A revision surgery was required in only 8.5% of cases. During the 12-month follow-up period, no cases of sympathetic ophthalmia were reported [Supplementary material 3 ^{(388.3KB, tif)} ].

Comparison of quality-of-life questionnaire scores at 12-month follow-up

No significant differences were observed in the composite score of the NEI-VFQ25 during the follow-up period. Additionally, the results indicated that the PSS and the two composite criteria (PCS and MSC) of the SF-36 questionnaire were not significantly different [Supplementary material 4]. Regarding the evolution of the NEI-VFQ-25 subscales, a significant improvement was observed in the domains of peripheral vision and dependency (P < 0.01). Other domains demonstrated no statistically significant change, indicating a stable visual quality of life [Fig. 2].

Supplementary material 4.

Comparison between the quality-of-life questionnaire scores at 3 months and at 12 months

	3-month follow-up Mean (±SD)	12-month follow-up Mean (±SD)	P
PSS	13.10±7.45	13.75±5.86	0.59
NEI VFQ-25	71.58±20.73	73.94±21.82	0.34
PCS	66.78±23.49	73.01±23.75	0.44
MCS	67.37±21.14	67.73±19.62	0.90

SD: standard deviation, PSS: Perceived Stress Scale, NEI VFQ-25: National Eye Institute Visual Functioning Questionnaire 25, PCS: Physical Composite Score and MCS: Mental Composite Score

Figure 2.

Histogram of the comparison between the NEI-VFQ-25 subscale scores at 3 months and 12 months. The white bars represent the 3-month follow-up period, and the black bars represent the 12-month follow-up period. ***Peripheral vision and dependency show significance with P < 0.01

Correlations between quality-of-life questionnaire scores correlations

At the 3-month follow-up, the PSS was negatively correlated with the PCS (Coef -0.587 P = 0.001) and the MCS (Coef -0.623 P < 0.001). A positive correlation was found between the VFQ-25 and the PCS (Coef 0.507 P < 0.01). A significantly positive correlation was found between the VFQ-25 and the MCS (Coef 0.402 P = 0.03), as well as between the PCS and the MCS (Coef 0.389 P = 0.03). Regarding the correlation of scores at the 12-month follow-up, the PSS was negatively and correlated with the PCS (Coef -0.627 P < 0.001), the MCS (Coef -0.586 P = 0.001), and the VFQ-25 (Coef -0.587 P = 0.001). The positive correlation was significant between the VFQ-25 and the MCS (Coef 0.471 P = 0.01) [Table 2].

Table 2.

Correlation between the quality-of-life questionnaire scores at 3 months and at 12 months

Scores	3-month follow-up		12-month follow-up
	Coefficient	P	Coefficient*	P
PSS – VFQ-25	-0,33	0,077	-0,58	0,001**
PSS – PCS	-0,58	0,001**	-0,62	<0,001**
PSS – MCS	-0,62	<0,001**	-0,58	0,001**
VFQ-25 – PCS	0,50	<0,01**	0,37	0,053
VFQ-25 – MCS	0,40	0,03**	0,47	0,011**
PCS – MCS	0,39	0,03**	0,24	0,226

According to Shapiro–Wilk tests, the Spearman rank correlation was used if scores were normally distributed; if not, the Pearson correlation test was applied. ** indicates significance. PSS=Perceived Stress Scale, NEI VFQ-25=National Eye Institute Visual Functioning Questionnaire 25, PCS=Physical Composite Score and MCS=Mental Composite Score

Factors associated with poor quality of life

In the multivariate analysis, a poor visual health-related quality of life as measured by the VFQ-25 was significantly associated with a history of retinal detachment in studied eye at 3 months and at 12 months (respectively coef -14.980 P < 0.05 and coef -26.624 P < 0.01). Regarding the quality of life at 3 months as measured by the PSS, a stroke history and postoperative pain were identified in the multivariate analysis (respectively coef 8.909 P < 0.01 and coef 6.079 P < 0.01). At 12 months, the age was identified as a significant alteration of the PSS score and the PCS score in the multivariate analysis (respectively coef 0.065 P < 0.05 and coef -0.717 P < 0.05). In multivariate analysis, the highest and most significant coefficient was observed with a stroke history and PCS at 3 months (coef -43.534 P < 0.01) and 12 months (coef -44.211 P < 0.001) [Table 3].

Table 3.

Univariate and multivariate analyses for PSS, NEI-VFQ-25, and PCS scores at 3 months and at 12 months

Analysis (Coefficients)	PSS score		NEI-VFQ-25 score		PCS score
	Univariate	Multivariate	Univariate	Multivariate	Univariate	Multivariate
3-month follow-up period
Retinal detachment	4,374	-	-26,023**	-14,980*	-6,879	-
Postoperative pain	8,427**	6,079*	-7,019	-	-12,344	-
Stroke history	11,640**	8,909**	-28,519**	-1,076	-43,534**	-40,923*
Scar necrosis	9,741	-	-51,551**	-34,610*	-14,447	-
12-month follow-up period
Age	0,144*	0.065*	-0,400		-0,923**	-0.717*
Retinal detachment	5,174	3.221	36,200***	-26.624**	-19,559	-
Stroke history	9,613**	5.473	-30,401*	13.386	61,230***	-44.211**
High blood pressure	0,905	-	-7,328	-	-31,299**	-27.059*
WHO score	2,196	-	-16,280***	-12.156**	-16,247**	5.854

*indicates significance with P<0.05, **indicates significance with P<0.01, ***indicates significance with P<0,001, PSS=Perceived Stress Scale, NEI VFQ-25=National Eye Institute Visual Functioning Questionnaire 25, PCS=Physical Composite Score, WHO=World Health Organization

Discussion

The results of this study provide insight into the evolution of the multidimensional HRQoL in patients who have undergone an eye amputation surgery within the first postoperative year. Despite the significant functional loss and esthetic alterations associated with these surgical procedures, our data show that patients generally maintain a stable and satisfactory quality of life 1 year after surgery. This can suggest an adaptation to their new condition. This hypothesis of positive adaptation over time regarding the dimensions of the HRQoL is reinforced by the correlation of the scores at 3 months and at 12 months. These correlations provide important information about the validity, relevance, and consistency of the study’s results.

The NEI-VQF-25 score indicated that although vision loss is a determining factor, patients achieve a satisficing level of stability in their visual quality of life after 12 months. This result could be explained by the fact that the majority of patients exhibited chronic vision loss, allowing adequate time for adaptation to their visual condition prior to undergoing surgery. Concerning the subscales of the NEI-VQF-25 score, it is interesting to note the significant improvement in peripheral vision and dependence on others over the course of the follow-up. Contrarily to the other studies, the peripheral visual field loss is notably highlighted as a recurring concern in patients who have undergone eye amputation.[16,17,18,19]

The PSS-10 exhibited a minimal change over the 12-month period and was better than that of the French population in the study by Lesage et al.[14] These results of the PSS-10 score could suggest a gradual positive psychological adaptation to their new condition that was maintained over the follow-up period. As the patients were monitored regularly for prosthetic care, it is plausible that the continuity of care during the medical follow-up assisted them manage their perceived stress over time. Furthermore, the patients underwent a preoperative ophthalmological consultation, during which they received comprehensive information regarding the procedures and treatments. A significant proportion of the patients, precisely 25%, were admitted for emergency surgery. In such contexts, patients encounter challenges in completing the questionnaires with confidence as the surveys are designed to assess HRQoL over the previous month. Consequently, the evaluation of global, visual, and psychological HRQoL prior to surgery was not feasible in the present study. Additionally, 68% of patients had a preoperative visit with an ocularist, which provided reassurance on esthetic and emotional levels. The preoperative preparation and the postoperative monitoring of the patients may have contributed to the early management of stress and established a solid baseline for their HRQoL at the outset of the follow-up period. Indeed, Saxby et al.[7] emphasized the importance of patients being informed about the final cosmetic outcome and prosthesis fit.

The SF-36 score confirmed that the physical and mental dimensions of quality of life do not significantly deteriorate over time following the intervention. Regarding the MCS score, many previous studies described these psychologic limitations long time after an eye amputation surgery.[8,9] In the present study, the follow-up of 12 months could be too short to highlight a significant enhancement. Moreover, regarding the PCS score, the results showed a tendency to improve over 12-month follow-up. This could suggest a positive impact of the prothesis adaptation and the time on the general physical health. Indeed, in the multivariate analysis, the main factor affecting HRQoL, particularly in the PCS at 3 months and at 12 months, was a history of stroke.

These results of nondeterioration or tendency to improve of HRQoL may also be explained by the very low rate of complications over the follow-up period. In accordance with the other studies, the most common complications were phantom visions (26%) and phantom pains (17%). The majority of studies have reported a prevalence of phantom vision in approximatively 33 to 48.2% of patients,[20,21,22] and of phantom pain in about 18.4 to 23%[22,23] which can occur in the first 6 months after surgery. Brown et al.[22] demonstrated that anxiety could be a major risk factor for the onset of phantom eye syndrome when it appeared within 4 weeks of surgery.

As previously described, many factors can impact the dimensions of HRQoL. This study significantly demonstrated that a history of stroke had the detrimental effect on HRQoL following eye amputation surgery. Other studies have shown that patients with visual impairments and associated stroke symptoms experience a marked reduction in HRQoL, particularly limit their ability to perform daily activities, and maintain a good level of physical quality of life.[24,25,26,27] In this context, it was challenging to distinguish between the stroke history and the surgery.

Conclusion

HRQoL remains stable or improves in several dimensions 12 months after eye amputation. This suggests a positive adaptation to their condition. Since the three dimensions of the HRQoL are correlated, more effective management of perceived stress and the development of visual and physical rehabilitation strategies could contribute to an improvement in the HRQoL during the overall follow-up period (preoperatively, intraoperatively, and postoperatively).

Authors contribution

Conceptualization: LS; Methodology: LS; Validation: LS; Formal analysis: LS, RY; Investigation: LS, CS and KB; Statistical analysis: RY and CS; Writing—original draft: LS, KB, and CS; Writing—review and editing: LS, RY, MS, MA and ASG; English spelling and grammar: MS; Visualization: LS; Supervision: RY and LS

All authors have read and agreed to the published version of the manuscript.

Conflicts of interest:

There are no conflicts of interest.

Supplementary material 1

Pie chart of the ocular diseases leading to eye amputation surgery

Supplementary material 2

Histogram of the distribution of surgical procedures performed

Supplementary material 3

Histogram of the distant postoperative complications at the 12-month follow-up visit

Funding Statement

Nil.