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Journal Français d'Ophtalmologie
Volume 41, n° 1
pages e1-e9 (janvier 2018)
Doi : 10.1016/j.jfo.2017.11.002
Received : 28 August 2017 ;  accepted : 14 November 2017
Editor's choice

Toric lens implantation in cataract surgery: Automated versus manual horizontal axis marking, analysis of 50 cases
 

M. Raucau , H. El Chehab, E. Agard, C. Lagenaite, C. Dot
 Service d’ophtalmologie, HIA de Desgenettes, Bron, 1, place du Change, 69005 Lyon, France 

Corresponding author.
Summary
Subject

The main objective of our study was to evaluate the contribution of automated conjunctival registration in the alignment of toric intraocular lenses by comparing automated registration optimized with Callisto® to manual marking of the horizontal axis.

Materials and methods

We performed a prospective, descriptive, monocentric study on patients undergoing cataract surgery with a toric intraocular lens (Asphina 709 Zeiss), performed by a surgeon with good experience in toric implants, between September 2016 and March 2017. We analyzed the agreement between the manual marking of the 0–180° axis versus the one automatically generated by the Callisto™, as well as the alignment of the IOL and the refractive results at 1 month.

Results

We included 50 eyes of 38 patients. The mean corrected astigmatism was 1,9 D. The mean difference between the 2 axes was 4,7° [0–12.3°]. Only 50 % of the preoperative manual markings were consistent with the automated measurement (<5°). At one month, the mean rotation recorded was 4,3° [0–29°]. The alignment was identical for 70 % (n =35) of the IOLs (≤5°). As for residual subjective astigmatism, the mean was 0.58 D. The mean visual acuity without correction was 8/10 and 55 % saw 10/10 without correction.

Discussion

Refractive performance depends on preoperative measurement, correct alignment of the IOL and its stability in the bag. Our study shows the value of automated conjunctival registration in the determination of the intraoperative axis of alignment, even with an experienced surgeon. This precision is essential for a good refractive result, especially since residual astigmatism in the case of misalignment will increase with the power of the implant.

Conclusion

Our study shows excellent refractive results, regardless of the initial astigmatism, using automated alignment. Precision of toric implantation opens the way to toric multifocal implantation under the best conditions.

The full text of this article is available in PDF format.

Keywords : Astigmatism, Toric intraocular lens, Cataract, Refractive surgery, Toric IOL alignment tools, Tracking


Introduction

Cataract surgery is the most commonly performed surgical procedure in France [1].

In the case of corneal astigmatism over 1 diopter (D), good distance vision requires glasses, despite correction of the spherical component of the refraction by an intraocular lens (IOL).

Correction of this astigmatism is possible at the time of the procedure and several options have already been available since the commercialization of toric platforms using virtual reality technology for alignment of the IOLs under the operating microscope.

We were interested in these technologies, which allow automated detection of the target axis of astigmatism, and studied their contribution in real life.

The primary goal of our study was to evaluate the role of conjunctival registration in the alignment of toric IOLs by a surgeon experienced in toric IOLs, comparing the axis generated automatically by conjunctival registration by Callisto® (Zeiss) to the manual axis based on an initial marking of the 0–180° axis by marking pen in a seated position as the reference axis for the Callisto®.

Materials and methods

This was a prospective, single-center, non-randomized, descriptive study from September 2016 to March 2017.

The patients included had to be eligible for cataract surgery, with corneal astigmatism equal to at least 0.75 diopter (D) against the rule or oblique, or greater than or equal to 1 D with the rule.

Exclusion criteria involved ophthalmologic comorbidities, which might limit total visual rehabilitation, such as congenital or acquired amblyopia, macular disease (age-related macular degeneration, diabetic maculopathy, atrophy…) and corneal abnormalities (irregular or progressive astigmatism, central corneal scars…).

All surgeries were performed by a single surgeon experienced with toric IOLs, with implantation of an AT TORBI 709 Zeiss® intraocular lens.

The surgeries were uneventful and the postoperative course unremarkable for all patients.

Preoperative work-up

All patients underwent a complete preoperative dilated ophthalmologic examination after biometry (performed prior to dilation).

Corneal topography was performed systematically to delineate the astigmatism (corneal component, lenticular component, axis, regularity and symmetry…) and rule out progressive corneal disease, which was an exclusion criterion.

Biometry was performed on an IOL master 700®, from which the spherical and cylindrical powers of the IOL were determined using an online calculator (#login). A reference image of the white of the eye and conjunctival vessels was taken during the visit.

Surgical procedure

Transfer of the preoperative data to the operating room was achieved using the FORUM Cataract Workplace® platform (Carl Zeiss Meditec), imported automatically by the Callisto® through the hospital network.

All patients underwent marking of the horizontal axis with a surgical felt tip marker in a seated position by the single surgeon for this study, with the patient's head straight and fixating on a reference mark on the wall 3 meters away with the fellow eye. After supine positioning, this manual axis was compared (on the preoperative photo) with the horizontal axis generated automatically by the Callisto from the conjunctival registration (acquired at the preoperative visit from an image of the eye during biometry with the IOL Master 700® [Carl Zeiss Meditec]). The Callisto® automated mode performs a “match” between the preoperative photograph of the limbal vessels (seated position) and the (supine) image under the operating microscope, to account for the natural cyclotorsion of the eye.

The intraoperative photographic data comparing the two axes of implantation were transferred at the conclusion of the procedure by FORUM® (Carl Zeiss Meditec) for subsequent analysis.

All implantations were performed using conjunctival registration.

The corneal incisions were performed in three incision technique: a 2.2mm clear corneal primary incision on the 120° meridian along with two side ports calibrated at 1mm, perpendicular to the primary incision (30° et 210°).

Surgically induced astigmatism was 0 with the rule and +0.2 against the rule and oblique.

The capsulorhexis, centered on the pupil, with a diameter of 5 to 5.5mm was also assisted by Callisto®.

Once the IOL was positioned near the desired axis, the viscoelastic was aspirated from behind the optic, then the IOL was placed in its final position.

The final alignment under Callisto® was also verified on the photographs from the conclusion of surgery and served as a reference for analyzing rotation of the IOL at 1 month (Figure 1).



Figure 1


Figure 1. 

Photograph of final alignment; the manual (felt tip) axis coincides perfectly in this case with the automated axis based on conjunctival registration.

Zoom

Postoperative analysis

At one month, a new photograph of the IOL position at the slit lamp, on retroillumination, was performed and analyzed with the EyeSuite® software (Luneau) (Figure 2).



Figure 2


Figure 2. 

One month measurement of axis using the protractor tool on the Eyesuite® software (Luneau).

Zoom

The 1-month postoperative examination included autorefraction, assessment of the uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA) and lowest possible cylinder to achieve BCVA (residual subjective astigmatism).

From the intraoperative photographs, we analyzed:

cyclotorsion on the photograph from the start of the surgery (supine position): reanalyzed with the protractor tool on the Eyesuite® software. This corresponds to the rotation of the manual axis upon lying supine;
agreement between the manual and automated alignments: difference between the manual felt tip 0–180° axis to that generated automatically by the Callisto®. A tolerance of ±3° considering the thickness of the felt tip was allowed. If the difference was less than 3°, the two axes were considered in agreement;
rotation of the IOL: difference between the intraoperative alignment and the 1 month alignment as measured precisely with the protractor tool on the Eyesuite® software.

All the intra and postoperative measurements were read subsequently in a double-blinded fashion.

The quantitative data were expressed as means and the qualitative data as percentages. The comparison of means between groups was performed with a Student's t -test. Visual acuities were converted into the logarithm of the minimal angle of resolution (LogMAR).

Results
Population

We included 50 eyes of 38 patients over the defined period. The sex ration was 1.7 women/men (38/24). Among the 50 eyes, there were 27 right eyes and 23 left eyes.

The mean age was 75.6±6.8 years [54–90 years].

Characteristics of the IOLs used

The mean astigmatism corrected by the IOL was 1.9 D ([1 to 5 D], median 1.5 D). The majority (58 %) of IOLs had a cylindrical power of 1 or 1.5 D, and 14 % (n =7) had a cylindrical power of 3 D or greater (Figure 3).



Figure 3


Figure 3. 

Distribution of cylinder powers.

Zoom

Primary goal
Comparison of the 2 axes of alignment, automated and manual

We observed no failure of the conjunctival registration; thus, the automated alignment was used in 100 % of cases.

The manual mark differed by a mean of 4.7° [0–12.3°] from the automated axis.

The two 0–180° axes provided by the two techniques (upon which the final axis of implantation is based) were superimposable (difference less than or equal to 3°) in 38 % of cases (Figure 4).



Figure 4


Figure 4. 

Difference in manual vs. automated 0°–180° axis.

Zoom

In 38 %, they differed by more than 6° (n =19), with 3 times as many right eyes as left eyes (14 vs. 5).

The mean difference was 5.6° for right eyes vs. 3.5° for left eyes.

The maximum difference was 12° and involved 2 eyes.

Secondary goals
Cyclotorsion

The mean observed cyclotorsion was 4.1°±2.91° [0–10.4°].

Twenty-six eyes exhibited an intraoperative clockwise cyclotorsion vs. 24 counterclockwise.

In the majority of cases, the cyclotorsion was less than or equal to 5° (68 %), but in 32 % of eyes (n =16), this cyclotorsion was greater than 5° and only 4 % of eyes (2/50) showed cyclotorsion of greater than 10° (10.4° for both eyes) (Figure 5).



Figure 5


Figure 5. 

Automated cyclotorsion.

Zoom

There was also no difference between right and left eyes (incyclotorsion in 55 % and 57 % respectively).

Postoperative rotation

Verification of the photographs from the conclusion of surgery confirmed that all the IOLs were aligned on the desired axis at the conclusion of surgery. At one month, this alignment was the same (at ±5°) for 70 % (n =35) of the IOLs. The mean observed rotation was 4.3° [0–29°]. For 22 % of eyes (n =11), it was between 5 and 10° and only 4 IOLs experienced a rotation of greater than 10° (11°, 12°, 13° and 29°) (Figure 6).



Figure 6


Figure 6. 

Distribution of IOL rotation at 1 month (in degrees).

Zoom

The mean axial length was 23.4mm (23.1 to 26.19mm; median 23.1mm).

In the group of eyes with AL less than 23mm, the mean rotation was 3.9° vs. 4.6° in the group with AL greater than or equal to 23mm (P =0.59). This mean exceeded 5° (5.04°, n =22) when the AL was greater than 23.5mm.

However, no statistically significant correlation was found between AL and IOL rotation in degrees (P =0.41).

As much clockwise as counterclockwise rotation was observed (48 % vs. 52 %) for this plate haptic IOL.

The mean rotation for IOLs positioned vertically (with the rule astigmatism) was 3.75° [0–13°] vs. 4.92° [0–29°] for horizontal implantations (P =0.39).

No rotation required repositioning of the IOL (UCVA7/10).

Visual acuity

Mean uncorrected visual acuity was 8/10 (+0.1 logMAR); over half of the patients (53 %) saw 10/10 SC. Mean BCVA was 9/10 (+0.05 logMAR).

Ninety-five percent of eyes saw at least 7/10 without correction (+0.16 logMAR) (Figure 7).



Figure 7


Figure 7. 

Distribution of uncorrected visual acuity.

Zoom

Mean UCVA for IOLs of 1 D and 1.5 D was 9/10.

VA and IOL rotation

A large majority of VA's of 10/10 SC (77 %) was observed for the eyes whose IOLs rotated 5° or less; however, even in the case of rotation in excess of 10°, UCVA was still satisfactory, between 7 and 10/10 (Figure 8).



Figure 8


Figure 8. 

UCVA as a function of IOL rotation.

Zoom

VA and cylinder power of the IOL

Mean UCVA of the low power IOLs (1 D and 1.5 D) was 9/10 (Figure 9).



Figure 9


Figure 9. 

UCVA as a function of IOL power.

Zoom

Almost all the VA's of 10/10 (92 %) were observed for cylindrical corrections of less than 3 D.

When the cylinder was >3D (n =6), the refractive result remained satisfactory for the patient (5 patients out of 6 with 7/10 SC).

Residual astigmatism

At one month, residual subjective astigmatism (still allowing 10/10 vision) was present in 40 % of cases, with the mean being 0.58 D [0.25–1.25 D].

Residual subjective astigmatism was less than or equal to 1 D in 98 % of cases.

Figure 10 details this residual astigmatism as a function of the cylindrical power of the implanted IOL.



Figure 10


Figure 10. 

Residual subjective astigmatism as a function of IOL cylindrical power; figures within the bars represent the number of the eye in question.

Zoom

Discussion

Wilkins et al. have reported that full-time glasses wear was 34 times more frequent per diopter of astigmatism in the better eye [2], and it is estimated that approximately 30 % of patients undergoing cataract surgery have regular corneal astigmatism1 D [3, 4, 5].

The prevalence of preoperative astigmatism in the literature is variable: approximately one third of eyes have astigmatism greater than 1 D according to Hoffmann and Hütz [4], while this figure is as high as 47 % in a Chinese study by Yuan et al. [6]. It is felt that astigmatism over 0.75 D may have consequences on patients’ quality of life (glare, halos, metamorphopsia, decreased VA…) [7].

Higher astigmatism (+3 D) is less frequent, on the order of 2.6 % [8].

In France, the market share of toric IOLs is approximately 7 %, which seems low, given the epidemiology of astigmatism.

Several techniques have been studied for the correction of corneal astigmatism during cataract surgery, the choice of which essentially depends on the magnitude of the astigmatism and surgeon preference.

He or she may choose to treat the cornea (“relaxing” incision in the steep axis [9, 10, 11], limbal keratotomies [12] and photorefractive keratectomy or laser in situ keratomileusis (LASIK) [13]) or to implant a toric IOL intraoperatively [14].

It was Shimizu et al. [15] who first described in 1994 the use of toric intraocular lenses clinically, and he demonstrated its efficacy in numerous subsequent series [5, 8, 16, 17, 18, 19, 20], notably for high astigmatism [20], although even for low astigmatism, visual benefits may be obtained [21, 22].

The cost of the IOL to the patient is largely compensated by the cost savings on distance glasses [23].

However, good knowledge of the indications and rigorous surgical technique are indispensible to assure a satisfactory result.

Preoperative determination of the power and axis of the astigmatism is often easy, regardless of the technique, as shown by a study comparing manual and automated keratometry, IOLmaster® and Pentacam® [24, 25], but marking is sometimes more complex.

The latter is subject to three potential errors when marking manually:

identifying the 0–180° axis;
identifying the axis of implantation using the former as a reference;
positioning the IOL.

Technological advances have made toric IOL implantation increasingly precise and accessible to surgeons, decreasing errors in measurement and calculation.

We know that refractive performance depends on preoperative measurement, good intraoperative alignment of the IOL and its stability in the bag [6, 26].

There is a 30 % loss of efficacy of the IOL for every 10° of rotation [24], which means that in the case of rotation of 30° or more, there will be complete residual astigmatism, but in a different axis [27].

The application of new technologies based on virtual reality theoretically allow optimization of IOL alignment and the final refractive result.

The efficacy of these have been shown in studies by Miyata et al. [28], who used corneal topography to improve the precision of marking the axis of implantation.

Our study reports that, for the same patient whose eye is its own control, the two techniques, manual and automated (based on conjunctival registration), differ only by a mean of 4.7° for marking the horizontal axis. The surgeon is experienced in toric IOLs, which must be taken into account as to the quality of manual marking. However, in half of the cases, this difference was greater than 5° [6–12°], thus potentially affecting the refractive outcome of the eyes undergoing surgery, even more so the higher the cylindrical power of the IOL. In addition, it appears that manual marking may be influenced by laterality for this right-handed surgeon, with a larger discrepancy between the two techniques observed in right eyes. Finally, automated registration, with a 100 % match, bypasses the difficulty in manual marking for patients who are at times uncooperative (lid closure, Bell's phenomenon, diffusion of the ink…).

One will note that the error in final positioning of the IOL with the classic manual method of marking induces a difference greater than 4.7°. Thus, a possible error in the manual marking of the axis of implantation with a Mendez ring as well as an error in IOL positioning adds to the error in marking the 0–180° axis.

The refractive results of the study based on automated alignment and keratometry by the IOL Master 700® appear very satisfactory, with UCVA 8/10 on average, comparable to other studies [29, 30] and this with 22 % of the cohort receiving a cylindrical power greater than or equal to 2.5 D. The greater the toric power, the more important the precision of the alignment technique.

No comparative study using the Callisto is available; however, Elhofi et Helaly have compared manual marking vs. automated registration with Verion® in two groups of 30 patients and did not demonstrate a significant difference in visual acuity or residual astigmatism between these two groups, but did show a slight misalignment of the IOL in the Verion® group [27].

Lin et al. found a difference between the horizontal reference axis of the Verion® and the axis marked manually, either subjectively or using a horizontal slit beam, of 6.94° and 3.66° respectively [31].

With regard to manual marking, regardless of the method of registration and/or marking of the axis, this must be performed with the patient seated, so as to bypass the issue of cyclotorsion of the eye. The observed mean cyclotorsion of 4° in our study is comparable to other works in which it is generally reported to be 2 to 3°, although it may reach 14° [27].

In one third of cases, we found that it may exceed 5° in our study, which could thus impact the patient's refractive result if it is not taken into account by the surgical technique.

Numerous risk factors for toric IOL rotation have been identified:

axial length [32];
inappropriate capsulorhexis size and centration;
insufficient aspiration of viscoelastic;
intraocular pressure variations and axis of implantation (more rotation if placed vertically) [33, 34].

The mean rotation of our IOLs was 4.3°, which is in agreement with a recent review of the literature by Argresta et al., who reported values of 2.66° to 8.9° [35]. This variable must be analyzed as a function of IOL design, in our case a plate haptic IOL.

The technique for measuring this rotation varies between studies and is sometimes complex. The protractor tool used in our study on the postoperative photos was simple, reproducible between the two readers and precise. IOL rotation was greater in eyes with longer axial length, but not significant (P =0.59). One of the explanations offered by Potvin et al. for this phenomenon is that these eyes receive thinner IOLs and have a more fragile zonular apparatus, which might influence the stability of the IOL [36]. This variable certainly merits discussion, as does IOL design, and our limited sample (n =50) limits the power of the statistical analysis (insignificant correlation).

This last study also described more frequent clockwise rotation of the IOL, which we did not find with the 709MP® IOL used herein.

Finally, the larger rotation of IOLs aligned vertically was not confirmed by our study. These objective measurements of IOL position are not always perfectly correlated with the patient's subjective opinion and visual acuity.

In our study, mean subjective residual corneal astigmatism was 0.6 D, of the same order as for Humbert et al. [29] and Potvin et al. [36], although this figure is variable in the literature, ranging from 0.176 to 0.81 [22, 37, 38].

In their series comparing toric to non-toric IOLs, Holland et al. had residual subjective astigmatism less than or equal to 1 D [39]. It is important to highlight that this residual astigmatism is multifactorial, implicating each step in the process, from preoperative measurement of astigmatism to postoperative IOL stability, without forgetting variations in surgically induced astigmatism, which are not predictable in 100 % of cases. However, we reported in a previous work that the three-incision technique used for all the procedures allowed for excellent control of surgically induced astigmatism [40].

Posterior corneal astigmatism not yet taken into account routinely by calculation formulae may explain in part this sometimes-surprising residual astigmatism and remains an area for improvement in the very near future.

Limitations

The limitations of our study are related to the small sample size (50 eyes) and the absence of use of a pendulum system for manual marking, which is not used by the surgeon — felt to be impractical or even laborious for use on anxious patients. We do not have a control group with IOL alignment based on the manual markings using the same methodology. Finally, the follow-up is short term (1 month), but several studies suggest that the majority of toric IOL rotations occur early, within the first 14 days [33, 36].

Strong points

The strong points of our study are its prospective design, its methodology with a single surgeon, a single type of IOL, and one eye which is its own control for the analysis of the difference offered by the two alignment techniques. Finally, the analysis of the images was performed in a double-blinded fashion by two different surgeons. We have also demonstrated a role for this technology, even in the hands of an experienced surgeon, not only for refractive results, but also for workflow.

Conclusion

The use of the automated reference axis of the Callisto combined with the IOL Master 700, the basis of the Cataract Work place™ (Zeiss), has demonstrated excellent refractive results in our series.

This study shows the reproducibility of conjunctival registration and the impact on final IOL alignment in half of the patients for at least 5°. A difference of 5 to 10° may impact the refractive outcome, even more greatly the higher the cylindrical power of the IOL used.

A face-to-face comparative analysis with IOL alignment based on manual marking, with larger populations, should be performed to complement these results.

Disclosure of interest

Corinne Dot is a consultant at Alcon, Hoya and Zeiss. The other authors declare that they have no competing interest.


 Oral presentation presented at the 123rd Congress of the French Society of Ophthalmology in May 2017.

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