Comparison of trainee versus consultant outcomes in immediate sequential bilateral cataract surgery in the UK: A two-armed cohort study.

doi:10.21203/rs.3.rs-4440971/v1

Purpose:

To compare the outcomes of Immediate Sequential Bilateral Cataract Surgeries (ISBCS) performed by trainees versus consultant ophthalmologists at Moorfields Eye Hospital and its satellite centres.

Methods:

Reviewed ISBCS surgeries by phacoemulsification and intraocular lens implant performed by trainee ophthalmologists (Gr1) and consultant ophthalmologists (Gr2). Studied complications, refraction outcome (spherical equivalent SE > 0.5D and > 1.0D), and uncorrected distance visual acuity (UDVA logMAR) at 3 months post-ISBCS.

Results

553 eyes in Gr1 and 687 in Gr2. Intra and postoperative complications were similar between trainees and consultants [RR = 1.88 (95% CI 0.8; 4.2) P = 0.13]. Median SE in Gr1 [-0.12 D (IQR − 0.5; -0.25)] and Gr2 [-0.25D (IQR − 0.63; -0.13)] showed no significant difference (MW P = 0.08). Predicted median PCR risk was higher in Gr1 [1.54 (IQR 1.04; 2.16)] than in Gr2 [1.16 (IQR − 0.84; 1.7)] (MW P < 0.001). Postoperative SE > 0.5D occurred in 19.2% of Gr1 and 15.7% of Gr2 (P = 0.123). Postoperative SE > 1.0D occurred in 6% of Gr1 and 3.9% of Gr2 (P = 0.142). UDVA post-surgery was similar in both groups (MW P = 0.26). Surgeon type, PCR risk, and predicted refraction were not significant predictors of postoperative SE > 0.5D.

Conclusions

ISBCS outcomes by trainee ophthalmologists were similar to those by consultants. Higher PCR risk in eyes operated by trainees suggests the need for more supervised training.

Scientific community and society/Scientific community/Education

Health sciences/Health care/Health care economics

Health sciences/Health care/Health services/Rehabilitation

Cataract surgery

ISBCS

refractive outcome

capsular tear

Immediate sequential bilateral cataract surgery (ISBCS) involves operating on both eyes of a single patient sequentially on the same day, with each eye being considered a separate sterile procedure. ISBCS has gained popularity since the COVID-19 pandemic restrictions resulted in a backlog of unoperated cataracts worldwide. [ref 1, 2] ISBCS allows faster visual rehabilitation, improved vision-related quality of life, and higher productivity than delayed sequential bilateral cataract surgery (DSBCS) and unilateral cataract surgery. [ref 3] ISBCS is preferred by patients. It is cost-effective and, therefore, promoted by service providers. [ref 4] During the COVID-19 pandemic, ISBCS also helped to reduce the risk of viral spread between patients and between patients and surgeons by reducing the number of hospital attendances. [ref 5] However, among ophthalmologists, ISBCS is still not a widely accepted option to manage bilateral cataracts due to the risk of bilateral complications such as infection, inflammation, and corneal edema, the inability to adjust intraocular lens (IOL) power in the second eye and thus address refractive surprise, and the paucity of evidence or protocol to shift to ISBCS from DSBCS. [ref 6,7] The increasing acceptance of ISBCS in well-selected cases is evident by the International Society of Bilateral Cataract Surgeons. [ref 8, 9]

The experience level of operating surgeons may affect the outcomes of ophthalmic surgeries. This is a possible risk factor to be considered while promoting ISBCS at training institutions. The outcomes of ISBCS by the consultant were not significant in a study of 100 participants at a teaching hospital in the UK. [ref 10]. Ĉhen et al. noted that surgery completed in 14 patients through ISBCS by senior residents in India during the COVID-19 pandemic was as safe and effective as DSBCS. [ref 11] However, since these studies have a relatively small number of participants, the impact of surgeon experience needs to be further reviewed.

We present the outcomes of ISBCS performed over three years by trainee ophthalmologists and consultants at Moorfield Eye Hospital and its satellite centers across London, UK.

The study was performed at Moorfield’s Eye Hospital, a large tertiary referral center and teaching hospital, and its satellite sites across London, UK. It was registered and approved under the local Clinical Effectiveness Unit of Moorfields Eye Hospital. The hospital data was retrospectively accessed without interacting with patients. Therefore, informed written consent was waived. The personal identity was delinked from other data before analysis. The tenets of the Helsinki Declaration were strictly abided at different stages of the research.

This was a two-armed retrospective cohort study. All adult patients undergoing ISBCS at Moorfields Eye Hospital between March 2020 and March 2023 were included. Any patients having a combined non-cataract procedure were excluded. For our patient search and data collection, an electronic database was used (OpenEyesTM, UK). No paper records were used since all information required is recorded in the electronic database. This produced a data set of 624,397 patients (1,245,794 eyes). Data collected included the patient’s age, operating surgeon, level of the operating surgeon, preoperative visual acuity and refraction (autorefraction), IOL type and power used, predicted post-operative spherical equivalent from biometry, intraoperative complications, postoperative vision and refraction, and postoperative complications for both eyes in the three months after surgery.

Many consultant ophthalmologists, specialist trainees, and fellows performed the surgeries. The specialist trainees were subdivided into Lower House (LH) (specialty trainee year 4 (ST4) or below) and Upper House (UH) (Specialty trainee year 5 (ST5) or above). For analysis, eyes operated by trainee surgeons were grouped into Gr1, and eyes operated by consultant surgeons were grouped into Gr2. The consultants operated cataracts under topical anesthesia. The trainee ophthalmologists operated on cataracts under the supervision of a consultant under sub-tenon local anesthesia if needed.

We assumed that senior residents had a success rate of achieving a spherical equivalent (SE) within 0.5D of the predicted post-operative refraction in 77% following ISBCS. [ref 11] The same outcome was 85% when operated by consultants. [ref 12]

To achieve a 95% confidence interval and 90% power to a cohort study with a 1:1 ratio in a cohort study, we need at least 553 ISBCS in each arm of the cohort. Since Gr1 had 553 eyes and Gr2 had more eyes during the study period, we included all the cases. We used open epi software to calculate the sample size for a cohort study. [ref 13]

Four trainees’ ophthalmologists and two consultants were the study investigators.

All patients listed for surgery were assessed in one-stop cataract clinics. They all had anterior segment and dilated fundal examinations, OCT macula (SPECTRALIS OCT, Heidelberg Engineering, Germany), and biometry performed using the IOL-Master 700 (Carl Zeiss Meditec AG, Germany). All patients were offered a mono-focal lens, and this was selected based on the SRK/T formula or Hoffer Q formula, depending on whether the axial length was above or below 22mm respectively. All patients were offered the choice of DSBCS and ISBCS.

All patients received a standard regime of pre-operative drops in each eye, consisting of Mydriasert (Thea Pharmaceuticals Ltd, France) or a combination of topical eyedrops e.g. tropicamide 1% and phenylephrine 2.5%. In theatre, ISBCS eyes were treated as two separate procedures with consumables from different baches as a mandatory requirement. Before the start of each eye, a separate WHO checklist and biometry check were done. [ref 14] The case selection, surgical procedures, and safety measures for undertaking ISBCS in the present study are described elsewhere. [ref 15] If both eyes were at similar risk, the consultant randomly selected the right or left as the first eye for surgery, and the trainee ophthalmologist operated on the fellow eye. The eye with advanced ocular comorbidity was operated on by the consultant.

All patients were given a standard post-operative drop regime, which consisted of Pred-forte 1% drops four times daily for two weeks followed by twice daily for two weeks and chloramphenicol 0.5% drops four times daily for two weeks. This may have been altered if there was an intraoperative complication. If a patient was at risk of post-operative cystoid macula edema, they were given acular 0.5% (Allergan, USA) drops four times daily for four weeks.

The post-operative review was face-to-face and generally at four weeks unless the procedure was complicated when the post-operative review was expedited. The pre and postoperative autorefraction enabled us to document the spherical and cylindrical values of the refractive status of each eye. The spherical equivalent (SE) of the eye was calculated using the formula spherical refraction (D) + (cylindrical refraction (D)/2). If SE 6 to 8 weeks after surgery was within ± 0.5D, we considered it an excellent outcome. If it was within ± 1.0D and UCVA after surgery was better than 6/18, we thought it an acceptable refractive outcome. If the post-operative deviation from predicted refraction was > ± 1.0 D with symptoms, it was considered a refraction surprise. [ref 16]

Posterior capsular rupture (PCR) included was with or without vitreous prolapse. [ref 17] The PCR risk is the predicted probability of PCR with or without vitreous loss vs composite Odds Ratio’ after adjusting for the patient's and surgeon's risk for PCR. The predicted refraction is defined as SE in the diopter of residual predicted refraction derived from the biometry sheet while selecting the IOL in the individual eye. [ref 18, 19]

We entered the data of the spreadsheet of the statistical package for Social Studies (SPSS 25) (IBM, NY, USA). We performed univariate analysis using the parametric method. The qualitative variables were presented as frequency and percentage. To compare the two variables in two groups, we used the Student’s t-test to calculate the two-sided P value. The continuous variables were plotted to study their distribution. Since they were skewed, we presented the median and interquartile range (IQR). To compare the outcomes in two groups, we used the Mann-Whitney U test to estimate the coefficient and two-sided P value. P value < 0.05 was considered statistically significant.

We included 553 eyes operated by trainee ophthalmologists (Gr1) and 687 eyes operated by consultants (Gr2). The demographic profile of Gr1 and Gr2 eyes undergoing ISBCS was compared. Table 1. Age was not significantly different between eyes performed by trainees and consultants. The surgery center and laterality of the eye in both groups varied significantly.

The ocular status of Gr1 and Gr2 before surgery are given in Table 2. The preoperative refraction and VA were similar in the two groups. The median PCR risk before surgery in Gr1 was 1.54 (IQR 1.04; 2.17), and in Gr2, it was 1.16 (IQR 0.84; 1.73). The PCR risk in eyes operated by trainees was significantly higher than in eyes operated by consultant ophthalmologists. (MW P <0.001). The predicted refraction before surgery in both groups was similar (MW P = 0.08)

The intra and postoperative complications in Gr1 and Gr2 are given in Table 3. The relative risk [RR] of intra and postoperative complications in eyes operated by trainee ophthalmologists was 1.88 (95% CI 0.8; 4.2) compared to the consultants. However, the element of chance observation cannot be ruled out. (P = 0.15).

The median SE 6 to 8 weeks after ISBCS in Gr1 was -0.125D (IQR -0.5; 0.25), while in Gr2, it was -0.25D (IQR -0.63; 0.13). The difference in SE of the two groups was similar. (MW P = 0.078) Table: 4.

The UDVA (logMAR) after ISBCS in Gr1 was 0.1 (IQR 0.0; 0.2) and in Gr2 it was 0.1 (IQR 0.0; 0.2). The difference between UDVA in the two groups was not significant (MW P = 0.26). Figure: 1

The correlation between PCR risk and post-operative SE in Gr1 was statistically significant (Wilcoxon signed Z = -18.0, P <0.001), and in Gr2 also, it was significant. (Wilcoxon signed Z = -17.4, P <0.001).

When we conducted a linear regression analysis, we found that the post-operative SE was not significantly correlated to PCR risk (P = 0.486) when the surgeon's experience (P = 0.18) was considered. [F =1.2, P = 0.31]

Postoperative SE >0.5D in 106 (19.2%) in Gr1 and 105 (15.7%) eyes of Gr2. (P = 0.123). Postoperative SE >1.0D in 33 (6%) in Gr1 and 27 (3.9%) eyes of Gr2. (P = 0.142).

Binary regression analysis to understand the interaction of preoperative factors on the postoperative SE >0.5D suggested that the type of cataract surgeon (P = 0.185), PCR risk (P = 0.177), and predicted refraction (P = 0.182) were not significant predictors of refraction surprises >0.5D.

The refractive status and attaining functional vision after ISBCS are similar if a trainee or experienced ophthalmic surgeon operates. The PCR risk is useful to note while auditing ISBCS and stresses the need for supervised surgeries by trainee ophthalmologists. The postoperative SE in eyes operated by trainee ophthalmologists compared to those operated by consultant ophthalmologists was similar. The rate of complications was comparable with the NOD standards.

The present study, held in a reputed eye service delivery unit in the UK, provides valuable information on promoting ISBCS by trainee ophthalmologists under the supervision of experienced eye surgeons. Post-pandemic, one strategy to address an increasing backlog of unoperated cataracts is promoting ISBCS. Surgeons, decision-makers, and patients will need evidence-based information to accept these surgeries in service-oriented situations. The outcomes of ISBCS performed by trainees were not inferior but will need training, supervised service delivery, and strict auditing using standard and acceptable indicators. The institutions with strict aseptic facilities and surgeons following protocols to perform ISBCS may use present study outcomes to their administrators and counsel patients while discussing ISBCS.

We did not find a difference in postoperative SE > 0.5D in the cataract surgeons' experience level. Both groups had refractive outcomes within the acceptable range recommended by RCOphth, UK. [ref 20] Providing spectacle-free distance visual acuity in both eyes and quick recovery are known goals of ISBCS. In an extensive series of patients undergoing ISBCS, Hanan et al. noted a 15% refraction outcome in monofocal and 13.8% in multifocal lens implants. [ref 12] Since, in our series, all cases were operated upon by providing mono-focal lenses per NHL guidelines, we noted similar outcomes in both groups as Hanan et al. reported for mono-focal IOLs in the UK. In contrast, a study in Turkey Ece et al. noted in a small series of 206 eyes undergoing ISBCS, 74% achieved < 0.5D SE, but all cases were < 1D SE. [ref 21] In the Netherlands, Spekreijse et al., 97% of 865 patients undergoing ISBCS in the second eye had < 1D SE 8 weeks after surgeries. [ref 22]

One of the disadvantages of ISBCS cited by ophthalmologists is their inability to adjust the refractive status of the fellow eye after the first eye is operated on. [ref 23] The UDVA post-surgery > 1logMAR was in 0.56% of eyes, 0.7% in consultant groups, and 0.4% in the trainee ophthalmologist group. With such a small number of eyes with UDVA > 1 logMAR 6 to 8 weeks after ISBCS, correcting refractive error in the fellow eye is less critical for patients.

We did not find a significant difference in intra and postoperative complication rates by level of experience of cataract surgeons. Although eyes with more complex cataracts are more likely to be operated by consultants, the outcomes were not different. The incidence of anterior capsule tear was higher in eyes operated by trainee ophthalmologists than by consultants. Better simulation of capsulorrhaxis could address this issue. [ref 24]

The risk-adjusted PCR rate is estimated before surgery to adjust for the surgeon’s skill and study site as an index to predict outcomes. The unadjusted PCR rate among the surgeons’ group was NOD's benchmark set (1.1%) in their published audit report 2020. The PCR rate was higher in trainee groups. However, trainee groups' outcomes were similar to those of consultants, reflecting that proper training and supervision can help minimize this risk.

The biometry instrument-based prediction of residual refraction in both groups was similar in our study. This could be due to the exclusion criteria of not including eyes with too long or too short axial length in the present audit. The selection of IOL was significantly different in the two groups. Further analysis with adequate samples of types of IOL, especially in the second eye to compensate for presbyopia, may be an area of research to investigate their impact on visual and refractive outcomes in ISBCS.

General ISBCS protocols recommend that consultants operate on the first eye using topical anesthesia, and the trainee ophthalmologist operates on the second eye using subtenon anesthesia (if needed) under the supervision of the consultant. The consultant should select the eye with higher complexity and higher PCR risk. Our study showed that the outcomes were similar in the two groups. Supervised training in ISBCS can provide an opportunity to improve trainee ophthalmologists' skills and outcomes. It will be interesting to study the differences in outcomes if trainee ophthalmologists operate first and then a consultant operates on the fellow eye. The stress and fatigue experienced by trainees in 2nd eye surgery could negatively affect their performance and outcomes. [ref 25]

The current practice of selecting and operating ISBCS in the UK differs from routine cataract surgeries. As many as 60% of them are performed under general anesthesia on younger patients and with lower risk of intra and postoperative complications. [ref 26] The audit included 4652 eyes undergoing ISBCS cataracts during 2022 through NHS, found it non-inferior to DSBCS, and suggested scaling up ISBCS surgeries in the UK. [ref 27]

Being a retrospective review of electronic health records, the study was affected by a ‘lost to follow-up’ bias. If 6% of eyes operated by trainees and 9% operated by consultants without UDVA at the last follow-up are considered to have functional vision, the difference could be marginally wider. Information on gender was not collected. Which eye was operated on first and which eye was operated on second in ISBCS is also not known. Therefore, factors related to stress and fatigue that influence the outcomes could not be reviewed. The information on phacoemulsification energy in each surgery was unavailable and could differ in two groups.

One important strategy to overcome the barriers to upscaling ISBCS is training for ISBCS. [ref 28] The introduction of such training in Laval, Canada, was innovative and worth mentioning. The ophthalmic educators may focus on such training and use simulators for bilateral cataract surgeries in one sitting. The eye hospitals/centers with a large volume of cataract surgeries are also suggested for making training hubs for ISBCS. [ref 29]

Information on non-inferior outcomes by trainees from reputed institutions like the present study site will be helpful to while counseling the cataract patients to opt for ISBCS. Using evidence and preparing written information on common themes and patients' concerns is recommended by Campbell et al. [ref 30]

This audit report from the Moorfields Eye Centers on ISBCS highlights the outcomes of surgeries by trainee ophthalmologists under the supervision of an experienced ophthalmologist, which are non-inferior to the surgery outcomes by consultant ophthalmologists. The low complication rate in both groups is heartening and encourages the promoters of ISBCS in the UK. Although the proposed target of achieving < 1D refraction in more than 85% is attained, surgeons should aim to improve their goal of achieving < 0.5D in more eyes undergoing ISBCS. The documentation of PCR risk before surgery showed differential risk in trainees vs consultants and its impact on reviewing the outcomes.

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Table: 1 Profile of eyes undergoing immediate sequential bilateral cataract surgeries (ISBCS) performed by consultants vs trainee ophthalmologists in the UK

		Trainee ophthalmologists (n = 553)		Consultants (n = 687)		Validation
Age	Mean (SDV)	71.1 ± 10.0		71.3 ± 11.1		P = 0.744
		Number	Percentage	Number	Percentage
Eye	Right Left	238 315	43.0 57.0	382 305	55.6 44.4	P <0.001
Site	City road Northwick Park St George's St Ann's Queen Mary's Ealing Potters Bar Community	226 91 192 13 18 6 7	40.9 16.5 34.7 2.4 3.3 1.1 1.3	200 171 214 39 30 20 13	29.1 24.9 31.1 5.7 4.4 2.9 1.9	P <0.001

Table: 2 Preoperative visual and ocular status in eyes undergoing immediate sequential bilateral cataract surgeries (ISBCS) by consultants vs trainee ophthalmologists in the UK.

Trainee ophthalmologists

(n = 553)

Consultants

(n = 687)

Validation

Spherical refractive error

Median

IQR

0.5

-1.5; 2.5

0.0

-2.75; 2.25

MW P = 0.03

Cylindrical RE

Median

IQR

-1.0

-1.5; -0.5

-1.0

-1.5; -0.5

MW P = 0.72

Preoperative UDVA (logMAR)

Number

Median

IQR

536

0.3

0.2; 0.5

665

0.3

0.2; 0.5

Z = -1.1

MW P = 0.263

IOL power (D)

Median

IQR

21.5

19.0; 23.0

21.0

18.5; 22.5

MW P = 0.02

Number

Percentage

Number

Percentage

Preoperative vision

6/6 to 6/18

<6/18 to 6/60

<6/60

Missing

449

52

32

10

81.2

9.4

5.8

1.8

553

72

45

12

80.5

10.5

6.6

1.7

Chi square = 0.65

Df = 2

P = 0.4

Type of IOL

SN60WF

Other

424

139

76.7

25.1

555

132

80.8

19.2

OR = 0.72, 95% CI 0.55; 0.95, P =0.02

PCR risk

Number

Median

IQR

513

1.54

1.04; 2.16

686

1.16

0.84; 1.71

Z = -5.3

MW P <0.001

Predicted refraction

Number

Median

IQR

550

-0.25

-0.36; -0.16

687

-0.26

-0.39; -0.17

Z = -1.74

P = 0.08

Table: 3 Intraoperative and postoperative complications in eyes undergoing immediate sequential bilateral cataract surgeries (ISBCS) by consultants vs trainee ophthalmologists in the UK

	Trainee ophthalmologist		Consultant ophthalmologists
	Number	Percentage	Number	Percentage
PCR	3	0.5	2	0.3
Anterior capsular tear	8	1.4	4	0.6
Iris prolapse/ trauma	3	0.5	3	0.4
Lens fragment in PC with vitreous loss	1	0.2	0	0.0
Zonular dialysis	0	0.0	1	0.1

Table: 4 Postoperative outcomes in eyes undergoing immediate sequential bilateral cataract surgeries (ISBCS) by consultants vs trainee ophthalmologists in the UK

Trainee ophthalmologists (n = 553)

Consultants (n = 687)

Validation

Spherical refractive error

Number

Median

IQR

480

0.25

-0.25; 0.5

576

0.25

-0.25; 0.5

MW P = 0.48

Cylindrical RE

Number

Median

IQR

480

-0.75

-1.25; -0.5

576

-0.75

-1.25; -0.5

MW P = 0.67

Spherical equivalent

Number

Median

IQR

480

-0.125

-0.5; 0.25

576

-0.25

-0.63; 0.13

MW P = 0.078

Post UDVA (logMAR)

Number

Median

IQR

Range

518

0.1

0.0; 0.2

-0.2; 1.3

624

0.1

0.0; 0.2

-0.3; 2.0

MW z = -1.1

P = 0.26

Postoperative SE >0.5D

Yes

No

Missing

106

374

73

105

471

111

P = 0.123

Postoperative SE >1.0D

Yes

No

Missing

33

447

73

27

549

111

P = 0.142

There is no conflict of interest

Comparison of trainee versus consultant outcomes in immediate sequential bilateral cataract surgery in the UK: A two-armed cohort study.

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