Informed consent in refractive surgery: in-person vs telemedicine approach

Figures & data

Table 1 Patient experience questionnaire

Postoperative day 1 questionnaire

Question 1. Overall how satisfied are you with the care that was provided by the surgeon? (1= very satisfied, 2= satisfied, 3= neither, 4= dissatisfied, 5= very dissatisfied)

Question 2. Overall how satisfied are you that the surgeon answered all of your questions? (1= very satisfied, 2= satisfied, 3= neither, 4= dissatisfied, 5= very dissatisfied)

One-month postoperative questionnaire

Question 3. Do you feel you were properly consented for surgery? (1= yes, 2= no)

Question 4. Thinking about your vision during the last week, how satisfied are you with your vision (without the use of glasses or contact lenses)? (1= very satisfied, 2= satisfied, 3= neither, 4= dissatisfied, 5= very dissatisfied)

Question 5. Would you recommend vision correction surgery to your friends and relatives? (1= yes, 2= no)

Question 6. Think about your vision during the last week. Please rate the degree of difficulty you experienced with: • starburst • glare • halos • ghosting/double vision • dry eyes (Measured on a discrete scale from 1= no difficulty to 7= severe difficulty)

Question 7. Because of your eyesight, how much difficulty do you have with driving at night? (1= no difficulty, 2= a little difficulty, 3= moderate difficulty, 4= a lot of difficulty, 5= never try to do this because of my vision, 6= never do this for other reasons)

Question 8. Because of your eyesight, how much difficulty do you have in doing work or hobbies that require you to see well up close, such as cooking, fixing things around the house, sewing, using hand tools, or working with a computer? (1= no difficulty, 2= a little difficulty, 3= moderate difficulty, 4= a lot of difficulty, 5= never try to do this because of my vision, 6= never do this for other reasons)

Question 9. Because of your eyesight, how much difficulty do you have in taking part in active sports or other outdoor activities that you enjoy (like hiking, swimming, aerobics, team sports, or jogging)? (1= no difficulty, 2= a little difficulty, 3= moderate difficulty, 4= a lot of difficulty, 5= never try to do this because of my vision, 6= never do this for other reasons)

Table 2 Preoperative and 1-month postoperative clinical outcomes of laser vision correction patients

Clinical/demographic variable	Consent type In-clinic Remote		P-value
Number of patients	1,626	6,558	–
Female/male ratio	45.8%/54.2%	47.4%/52.6%	0.23
Agea	34.4±10.8 (18–66)	33.8±10 (18–66)	0.03
Preoperative dataa
Sphere, D
Myopic sphere	−3.05±2.06	−2.77±1.84	<0.01
Hyperopic sphere	+1.37±0.95	+1.46±0.97	0.15
Range	(−11.25 to +4.75)	(−11.00 to +4.75)
Cylinder, D	−0.87±0.85 (0.00 to −6.00)	−0.78±0.72 (0.00 to −6.00)	<0.01
CDVA, logMAR	−0.06±0.06 (0.3 to −0.18)	−0.07±0.05 (0.3 to −0.3)	<0.01
One-month postoperative dataa
Sphere, D	+0.05±0.43 (+2.50 to −3.00)	+0.07±0.39 (+2.50 to −3.25)	0.01
Cylinder, D	−0.23±0.30 (0 to −3.25)	−0.20±0.26 (0 to −3.50)	<0.01
CDVA, logMAR	−0.08±0.06 (0.3 to −0.3)	−0.09±0.06 (0.52 to −0.3)	<0.01
Binocular UDVA, logMAR	−0.11±0.08 (0.52 to −0.3)	−0.09±0.09 (0.7 to −0.3)	<0.01

Note:

a These values are given as mean ± SD or mean ± SD (range).

Abbreviations: CDVA, corrected distance visual acuity; UDVA, uncorrected distance visual acuity.

Table 3 Preoperative and 1-month postoperative clinical outcomes of refractive lens exchange patients

Clinical/demographic variable	Consent type		P-value
	In-clinic	Remote
Number of patients	1,954	1,800	–
Female/male ratio	46.6%/53.4%	46.9%/53.1%	0.86
Agea	59.6±8.8 (19–88)	58.3±7.4 (21–85)	<0.01
Preoperative dataa
Sphere, D
Myopic sphere	−3.87±3.34	−2.83±2.23	<0.01
Hyperopic sphere	+2.44±1.69	+2.37±1.44	0.06
Range	(−16.75 to +10.75)	(−15.75 to +10.25)
Cylinder, D	−0.79±0.74 (0 to −6.75)	−0.62±0.55 (0 to −6.50)	<0.01
CDVA, logMAR	−0.02±0.09 (0.3 to −0.18)	−0.04±0.07 (0.3 to −0.18)	<0.01
One-month postoperative dataa
Sphere, D	+0.03±0.51 (+2.00 to −3.25)	+0.06±0.51 (+2.50 to −3.25)	0.003
Cylinder, D	−0.45±0.44 (0 to −4.00)	−0.43±0.40 (0 to −4.00)	0.05
CDVA, logMAR	−0.04±0.07 (0.7 to −0.18)	−0.05±0.07 (0.52 to −0.3)	<0.01
Binocular UDVA, logMAR	−0.03±0.10 (0.7 to −0.18)	−0.04±0.10 (0.6 to −0.18)	<0.01

Note:

a These values are given as mean ± SD or mean ± SD (range).

Abbreviations: CDVA, corrected distance visual acuity; UDVA, uncorrected distance visual acuity.

Figure 1 Postoperative satisfaction with visual acuity: patients who had a remote consent discussion with their surgeon vs patients who had a face-to-face discussion in the clinic.

Table 4 Visual phenomena and dry eyes

Postoperative symptoms	Postoperative mean score (mean ± SD)
	In-clinic	Remote	P-value
Laser vision correction
Number of patients	1,626	6,558
Starburst	1.58±1.13	1.59±1.16	0.75
Glare	1.65±1.14	1.67±1.16	0.62
Halo	1.57±1.12	1.55±1.10	0.63
Ghosting/double vision	1.34±0.93	1.25±0.79	0.0006
Dry eyes	1.96±1.31	1.96±1.29	0.99
Refractive lens exchange
Number of patients	1,954	1,800
Starburst	1.85±1.41	1.89±1.51	0.47
Glare	1.96±1.40	1.96±1.48	0.93
Halo	2.00±1.53	2.00±1.58	0.91
Ghosting/double vision	1.35±0.93	1.37±0.99	0.54
Dry eyes	1.77±1.23	1.79±1.24	0.60

Note: Each patient rated visual phenomena/dry eye difficulties on a scale from 1 (= no difficulty) to 7 (= severe difficulty) and the mean score for all patients was calculated.

Figure 2 Postoperative difficulties with various tasks: patients who had a remote consent discussion with their surgeon vs patients who had a face-to-face discussion in the clinic.

Notes: (A) Laser vision correction patients. (B) Refractive lens exchange patients.

Table 5 Results of multivariate regression analysis to predict outcomes of question 3: “Do you feel you were properly consented for surgery?” (R²=0.33, P<0.0001)

Independent variable	Univariate, P-value	Multivariate, P-value	Model contribution (%)
Age at treatment	>0.05	–	–
Gender	>0.05	–	–
Consent: in-clinic vs remote	0.04*	>0.05	–
Number of days between consent and surgery day	>0.05	–	–
Type of surgery (LVC or RLE)	>0.05	–	–
Preoperative sphere	>0.05	–	–
Preoperative cylinder	>0.05	–	–
Preoperative CDVA	>0.05	–	–
Postoperative sphere	>0.05	–	–
Postoperative cylinder	0.0003*	>0.05	–
Postoperative binocular UDVA	<0.0001*	<0.0001*	4.6
Change in CDVA	<0.0001*	0.003*	1.5
Day 1 surgeon care and questions (questions 1 and 2)	<0.0001*	<0.0001*	2.9
Month 1 satisfaction (question 4)	<0.0001*	<0.0001*	80.4
Month 1 impact of eyesight on various activities (questions 7–9)	<0.0001*	<0.0001*	3.7
Month 1 dry eyes (question 6)	<0.0001*	0.01*	1.0
Month 1 visual symptoms (starburst, glare, halo, ghosting/double vision; question 6)	<0.0001*	<0.0001*	5.8

Note:

* Statistically significant.

Abbreviations: CDVA, corrected distance visual acuity; LVC, laser vision correction; RLE, refractive lens exchange; UDVA, uncorrected distance visual acuity.

Figure 3 Postoperative satisfaction with visual acuity for patients who felt they were properly consented for surgery and those who did not feel so.

Figure 4 Postoperative difficulties with optical side effects compared between patients who indicated they were “properly consented” vs those who indicated they were “not properly consented” for their refractive procedure. “Significant difficulty”: patients who scored 6 or 7 on a scale between 1 (= no difficulty) and 7 (= severe difficulty).

Figure 5 Postoperative visual difficulties with various tasks based on patient’s perception of consent quality.