Rotation of a toric intraocular lens with and without capsular tension ring: data from a multicenter non-inferiority randomized clinical trial (RCT)

Abstract

Background Evaluation of clinical outcome in cohorts with versus without simultaneous implantation of a capsular tension ring (CTR) and a toric lens (Tecnis Toric). Main parameter was rotation referring - in contrast to misalignment - to the IOL axis change from immediately after implantation to the final postoperative position. Methods Lens position was measured at baseline with the patient still in recumbent position, postoperative rotation was calculated by software. Postoperative evaluation included measurement three months after surgery or prior to an indicated revision surgery. Explorative re-evaluation of the underlying RCT’s intent-to-treat population was performed for the entire sample and stratified for cohorts by 95% confidence intervals for binary endpoints’ incidences (primary endpoint: absolute postoperative rotation ≤5 degrees; secondary endpoints: absolute deviation between achieved cylinder and target cylinder ≤0.5 dpt, postoperative corrected distance visual acuity (CDVA) ≥ 0.8). Data exploration was based on medians and quartiles. Setting Outpatient study sites. Design Re-evaluation based on data from a multicenter non-inferiority randomized clinical trial (RCT). Results Sub cohorts (without CTR 89, with CTR 90 patients) did not present clinically relevant differences in preoperative characteristics: revision surgery was performed in 7 cases (3 without and 4 with CTR). Primary endpoint incidences for the total sample, without and with CTR were 90%/89%/90%; cylinder endpoint incidences were 46%/45%/46% and CDVA endpoint incidences 90%/92%/88%. Median absolute rotations were 1.74°/1.79°/1.72°, median absolute cylinder deviations 0.55/0.52/0.55 dpt and median visual acuity 1.0/1.0/1.0. Conclusion No clinically relevant differences between CTR subgroups were found; a satisfying three months rotational stability was achieved. Trial registration The trial was registered retrospectively in the trial registry DRKS, trial registration number DRKS00015316 , date of registration 27. August 2018.

Evaluation of Intraocular Lens Rotational Stability in a Multicenter Clinical Trial

“…2 A deviation of ≥5° may be clinically relevant, and a deviation of ≥10° may be an indication for secondary surgical intervention. 3,4 The TECNIS Toric 1-Piece (Johnson & Johnson Vision, Santa Ana, CA, USA) monofocal IOL is an ultraviolet lightabsorbing posterior chamber IOL that compensates for corneal spherical aberrations and corneal astigmatism. 5 Previous studies investigating the rotational stability of this 1-piece toric IOL have reported postoperative rotation in some participants.…”

“… 2 A deviation of ≥5° may be clinically relevant, and a deviation of ≥10° may be an indication for secondary surgical intervention. 3 , 4 …”

Comparative visual outcomes of EDOF intraocular lens with FLACS vs conventional phacoemulsification

“… 8 , 34 , 35 In this study, the Femto group achieved higher CS at intermediate to high spatial frequencies (6 to 18 cpd), especially at 6 to 12 cpd spatial frequency under glare condition, which indicated that patients who accepted traditional phacoemulsification were more likely to suffer from starburst, glare, halo, light spots, streaks, or color blocks in the field of vision, and the visual contrast would be worse with the appearance of strong light (such as sunlight and street lights). 5 …”

“… 4 The architecture of the capsulorhexis has a great influence on the position of the lens, which in turn affects the refractive effect. 5 If the capsulotomy is too large, the IOL optical system might be tilted or decentered, resulting in optical aberrations and damage to the retinal image. 6 Higher-order aberrations (HOAs) can produce visual errors, such as night vision difficulties and glare, halos, and other light disturbances, which could lead to falls, postural stability, and other difficulties in activities of daily living.…”

Effect of capsular tension ring on optical and multifunctional lens position outcomes: a systematic review and a meta-analysis

“…Because of a small sample and short range of follow-up, the result should assess carefully. (Figure 8) Only two randomized controlled trials [8,9] of small sample size reported the data of lens rotation in 3rd month. The result is no signi cant difference between two groups, the result should assess carefully.…”