Vision-related Quality of Life in Low-vision Patients Who Underwent Epiretinal Membrane Surgery

doi:10.21203/rs.3.rs-1530339/v1

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Vision-related Quality of Life in Low-vision Patients Who Underwent Epiretinal Membrane Surgery

https://doi.org/10.21203/rs.3.rs-1530339/v1

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Purpose

To evaluate vision-related quality of life (VR-QOL) in patients with preoperative low vision who had previously removed epiretinal membrane (ERM) with pars plana vitrectomy, and compared the results with the control group (CG).

Methods

In this retrospective and nonrandomized clinical study, 20 subjects with unilateral ERM and 20 healthy subjects as CG were included in the study. The Turkish-translated National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) was used. In all cases, under local anesthesia, the two-step 23 G vitrectomy was performed with a similar technique by the same experienced vitreoretinal surgeon.

Results

The preoperative best corrected visual acuity (BCVA) in ERM group was 1.04±0.41. Postoperative visual improvement reached statistical significance (p<0.001) and postoperative 6th month BCVA was 0.61±0.41. The postoperative 6th month composite score of NEI VFQ-25 was significantly lower in patients with ERM than in the CG (p=0.017). The preoperative subscale scores were significantly lower in the patients with ERM than in the CG in general vision, ocular pain, near activities and distance activities (p<0.001, p=0.005, p<0.001, p=0.003, respectively).

Conclusions

The NEI VFQ-25 questionnaire can discriminate ERM patients from healthy individuals, and visual acuity does not fully reflect VR-QOL. Impaired binocular vision may be associated with the deterioration of VR-QOL in patients with ERM in the postoperative period.

ERM

epiretinal membrane

NEI VFQ-25

vision-related quality of life

VR-QOL

Vision-related quality of life (VR-QOL) is a measure of the effect of visual impairment on daily activities and quality of life.[1] Recently, assessment of VR-QOL has involved using tools such as the National Eye Institute Visual Function Questionnaire (NEI VFQ-25).[2, 3] The 25-item NEI-VFQ-25 is preferred for evaluating the outcome of treatment of several eye diseases including cataract, keratoconus, glaucoma, age related macular degeneration, macular hole, epiretinal membrane (ERM), central serous chorioretinopathy, diabetic retinopathy, retinal vein occlusion and retinal detachment.[4–6]

Functional assessment and health-related quality of life questionnaires are becoming commonplace to measure the impact of ophthalmic treatments on patients' ability to perform visual functions. Recent studies have reported a correlation between NEI-VFQ-25 scores and visual acuity and a beneficial effect on VR-QOL with ERM removal.[7, 8] However, the preoperative visual acuity of patients who underwent ERM surgery in these studies is relatively good (0.50 logMAR or 6/24 Snellen). In this retrospective study, we evaluated vision-related quality of life (VR-QOL) in patients with preoperative low vision who had previously removed epiretinal membrane (ERM) with pars plana vitrectomy (PPV), and compared the results with the control group (CG).

All procedures performed in studies involving human participants were in accordance with the ethical standards of the Namık Kemal University Local Ethics Committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study.

In this retrospective and nonrandomized clinical trial, we evaluated 20 patients (20 eyes) who underwent 23 gauge transconjunctival PPV with internal limiting membrane peeling and air tamponade to treat ERM. Twenty healthy individuals as CG were included in the study.

Surgical Procedures

In all cases, under local anesthesia, the two-step 23 G vitrectomy (Stellaris PC; Bausch and Lomb, Rochester, NY, USA) was performed with a similar technique by the same experienced vitreoretinal surgeon (FH). Standard surgical procedure was core vitrectomy, removal of ERM and internal limiting membrane, fluid-air exchange. Additional phacoemulsification surgery was performed on phakic subjects in the same session. The patients used a postoperative 1 day face-down positioning.

Patients

The inclusion criteria were patients with unilateral idiopathic ERM treated with PPV and without complications during the operation. The exclusion criteria were any intraocular surgery except cataract surgery, proliferative vitreoretinopathy, intraocular hemorrhage, amblyopia, high refractive error, severe cataract, glaucoma, and vitreoretinal disorders. The patients were postoperatively called for routine control on the first day, first week, first month, third month, and sixth months. The patients’ preoperative, postoperative first month, third month and sixth month best corrected visual acuity (BCVA) were evaluated. BCVA was evaluated using a Snellen chart and converted to the logarithm of the minimum angle of resolution (logMAR) units.

The 25-Item National Eye Institute Visual Function Questionnaire

The VR-QOL was assessed by the NEI VFQ-25. NEI VFQ-25 was distributed to the patients in the Turkish language.[3] This questionnaire contains questions related to their general health status and 11 questions about visual perceptions of patients, including general vision, ocular pain, near activities, distance activities, social functioning, mental health, role limitations, dependency, driving, color vision and peripheral vision.

NEI VFQ-25 is scored including a continuous composite score and 12 subscales including general health, general vision, near vision, distance vision, driving, peripheral vision, color vision, ocular pain, role difficulties, dependency, social functioning and mental health. Each item in the survey is rated on five or six scales, resulting in a total score ranging from 0 to 100. Each subscale contains a range and four items. To obtain each subscale score, the average of their individual item scores is taken. The average score of 11 of the subscales is taken to obtain the composite score. According to the instructions of Mangione et al., the general health subscale is not included in the NEI VFQ-25 composite score. The NEI VFQ-25 composite and subscale scores are measured on a scale from 0 to 100, representing higher quality of life related to better vision.[2]

Statistical Analysis

All statistical analyses were performed using with NCSS version 12 (Utah, USA) and R Studio version 4 (Vienna, Austria). The Shaphiro-Wilk normality test was performed with the data set. The Pearson chi-square test was used for nominal ordinal data. The visual acuities of the ERM group were compared with the repeated measurement ANOVA test. Visual acuity and NEI VFQ-25 results of the CG and ERM group were compared with the Mann-Whitney U test. The relationship between the composite NEI VFQ-25 score and visual acuity was evaluated by simple linear regression. Reliability analysis was performed. Flexible discriminant analysis was performed to group individuals according to the NEI VFQ-25 results. Missing data were available in the driving category in patient with ERM. In the discriminant analysis, the missing data in the driving category was corrected according to the mean and the analysis was performed. Data were expressed as mean ± standard deviation. Significance levels were set at p < 0.05.

The average age was 67.6 ± 5.9 years in ERM and 64.4 ± 5.1 years in CG. There were no statistical difference (p > 0.05) between the groups in terms of age and gender. The demographic characteristics of the groups are presented in Table 1. The mean preoperative BCVA in the ERM group was 1.04 ± 0.41. Postoperative visual improvement reached statistical significance (p < 0.001) and postoperative 6th month BCVA was 0.61 ± 0.41. The change in postoperative visual acuity of ERM patients is presented in Table 2 and is schematized in Fig. 1. The postoperative 6th month BCVA was significantly lower in ERM patients than in the CG (p < 0.001). Visual acuity comparison of ERM and CG is presented in Table 3.

Table 1

Demographic characteristics of groups
	Control (20)	Epiretinal Membrane (20)	p
Age	64.4 ± 5.1	67.6 ± 5.9	0.080
Sex	8M/12F	9M/11F	0.749
Student t test, Pearson Chi-square test, significance level is p < 0.05, M:male, F:female

Table 2

Visual acuity change after epiretinal membrane surgery
	Mean ± SD	p
Preoperative BCVA	1.04 ± 0.41	< 0.001
Postoperative BCVA 1th month	0.73 ± 0.43	< 0.001
Postoperative BCVA 3th month	0.63 ± 0.40	< 0.001
Postoperative BCVA 6th month	0.61 ± 0.41	< 0.001
Repeated Measurements ANOVA test, significance level is p < 0.05, BCVA: best corrected visual acuity

Table 3

Visual acuity comparison of ERM postoperative 6th month and CG
BCVA	Mean ± SD		p
Control vs ERM (vitrectomized eye)	0.02 ± 0.02	0.61 ± 0.41	< 0.001
Control vs ERM (nonvitrectomized eye)	0.02 ± 0.02	0.05 ± 0.05	0.751
ERM (vitrectomized eye vs non vitrectomized eye	0.61 ± 0.41	0.05 ± 0.05	< 0.001
Mann-Whitney U test, significance level is p < 0.05, BCVA: best corrected visual acuity, ERM: epiretinal membrane, CG: control group

The results of the NEI VFQ-25 questionnaire postoperatively of the 6th month of ERM group and comparison with CG are presented in Table 4. The postoperative 6th month composite score of NEI VFQ-25 was significantly lower in patients with ERM patients than in the CG (p = 0.017). The subscale scores were significantly lower in the ERM patients than in the CG in general vision, ocular pain, near activities and distance activities (p < 0.001, p = 0.005, p < 0.001, p = 0.003, respectively).

Table 4

Comparison of NEI VFQ-25 between groups
	Control (20)	Epiretinal Membrane (20)	p
General health	50.00 ± 22.94	40.00 ± 24.87	0.221
General vision	80.00 ± 0.00	59.00 ± 15.18	< 0.001
Ocular pain	85.00 ± 9.60	66.25 ± 22.25	0.005
Near activities	85.00 ± 6.59	63.31 ± 19.00	< 0.001
Distance activities	85.00 ± 10.03	67.70 ± 21.54	0.003
Social functioning	95.00 ± 6.28	83.33 ± 22.38	0.108
Mental health	78.70 ± 17.01	71.56 ± 23.48	0.461
Role difficulties	65.00 ± 18.85	61.25 ± 21.42	0.758
Dependency	93.40 ± 6.48	91.24 ± 21.04	0.201
Driving	78.60 ± 9.79	54.12 ± 36.98	0.241
Color vision	88.75 ± 17.16	90.00 ± 12.57	0.968
Peripheral vision	65.00 ± 23.51	75.00 ± 22.94	0.242
Composite score	83.22 ± 8.49	71.95 ± 17.90	0.017
Mann-Whitney U test, significance level is p < 0.05

There was a statistically significant correlation between the composite NEI VFQ-25 score and visual acuity (R² = 0.19, p = 0.004). The regression graph, confidence intervals and prediction limits are presented in Fig. 2.

The scale has high reliability (Cronbach's alpha = 0.8743). The Cronbach’s alpha coefficient ranged from 0.880 to 0.846 for the subscales. It was found that our data did not meet the multivariate normality assumption (Mardia's Kurtosis test p < 0.001 and Mardia's Skewness test p < 0.001).The accuracy of the flexible discriminant function was found to be 100%. The 11 variables (except general health status) included in the analysis were expressed with 1 canonical variate. The distribution of the groups according to the canonical variate is presented in Fig. 3.

In our present study, we used the Turkish-translated NEI VFQ-25 questionnaire, which was developed to accurately characterize visual function with the self-reported dimensions. The reliability of the NEI VFQ-25 questionnaire was evaluated and was found to accurately measure VR-QOL. The NEI-VFQ 25 questionnaire was found to be able to discriminate between the ERM group and the CG. Missing data in the driving category may be due to populaton based differences (rate of having driving license or driving).

A successful ERM surgery results in mostly positive visual results.[9, 10] In our patients, increasing levels of visual acuity are also observed in their 6-month follow-up. Visual acuity may be poor in expressing many aspects of visual function and may be insufficient to predict whether individuals have difficulties in real-world activities.[11] Our results confirm this information and visual acuity explained 19% of the composite score of NEI VFQ-25. However, metamorphopsia after ERM surgery may persist[7, 12] and impair vision-related quality of life.[8] In our results, the composite score of patients with ERM remained lower than the CG, 6 months after a successful surgery. This situation is similar to previous studies of NEI-VFQ 25 assessment after ERM surgery.[8]

Binocular interference was defined as a situation in which the visual quality with both eyes open is worse than with only 1 eye, associated with the patient closing 1 eye. It was reported in a recent study that binocular interference worsens the quality of life of patients with ERM.[13] ERM is usually unilateral or asymmetrically bilateral.[14] The visual performance of the patients' fellow eyes was generally unaffected. Therefore, although the composite score of patients with unilateral ERM is lower than the CG, it is found that patients with ERM are similar to the CG in other categories, except for the categories of general vision, ocular pain and near and distance activities, as seen in the subscale. Although the visual acuity of patients with ERM has improved, it is seen that it does not reach a sufficient level compared to CG. Postoperative unequal vision levels may cause binocular interference and result in lower subscale categories compared to the CG. However, the thing to consider when evaluating these results is that we performed NEI-VFQ 25 questionare at postoperative 6th month. After ERM surgery, visual improvement has been reported in 43% of eyes at 12 month, 54% at 2 year, and 60% at 3 year[15], and this may lead to an improvement in NEI-VFQ 25 results in the long term.

In previous studies evaluating the postoperative NEI VFQ-25 results of ERM patients, mean NEI VFQ-25 composite score are as follows, respectively; 77.9[8], 78.5[4]. The mean composite scores of NEI VFQ-25 after vitreoretinal surgery in patients with macular hole, rhegmatogenous retinal detachment, proliferative diabetic retinopathy and age-related macular degeration have been reported as 82.4[16], 80.3[17], 68.5[18] and 54.4[19] respectively. In the present study, the mean composite score of NEI VFQ-25 was 71.9 and it was lower than the ERM patients reported in the literature and was similar to the score of proliferative diabetic retinopathy (PDR) patients. It should be noted that the composite score was better in diseases that usually affect only one side, such as ERM, macular hole and rhegmatogenous retinal detachment, than in diseases that usually affect both sides, such as PDR and age-related macular degeneration.

Ghazi-Nouri et al. reported a significant association between binocular BCVA and VR-QOL, but no association with VR-QOL for monocular BCVA, metamorphopsia, and contrast sensitivity in ERM patients.[7] Metamorphopsia in age-related macular degeneration[20] and vitreomacular traction[21] has been reported to be associated with VR-QOL. Another study reported that stereopsis was consistently altered in patients with ERM and was associated with VR-QOL.[22]

The limitation of our study is that we did not evaluate the preoperative NEI VFQ-25 score and did not evaluate the metamorphopsia and steropsis of the patients.

In conclusion, according to the reviewed literature, findings such as metamorphopsia and impaired stereopsis may persist in the postoperative period and may impair VR-QOL in patients with ERM. Diseases with binocular involvement affected VR-QOL more. In present study, we demonstrated that near and distance activity scores and ocular pain scores were worse in ERM patients with low visual acuity. We demonstrated that the NEI VFQ-25 questionnaire can discriminate ERM patients from healthy individuals and that visual acuity does not exactly reflect VR-QOL. To our knowledge, this is the first paper reporting NEI VFQ-25 after ERM surgery in Turkish population. More comprehensive studies are needed to evaluate the performance of the NEI VFQ-25 questionnaire to discriminate between other macular diseases.

Funding

No funding was received for this research

Conflict of Interest

No conflict of interest to declare

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the Namık University Ethics Committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Author Contributions

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by FH, HS, TY and OS. The first draft of the manuscript was written by FH, HS, CE and OAP and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

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No competing interests reported.

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Vision-related Quality of Life in Low-vision Patients Who Underwent Epiretinal Membrane Surgery

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Abstract

Figures

Intorduction

Matherials And Methods

Surgical Procedures

Patients

The 25-Item National Eye Institute Visual Function Questionnaire

Statistical Analysis

Results

Dicussion

Declarations

References

Additional Declarations

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