Format

Send to

Choose Destination
BMC Ophthalmol. 2019 Jul 8;19(1):143. doi: 10.1186/s12886-019-1147-5.

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

Author information

1
Institute for Medical Biometry and Epidemiology, Witten/Herdecke University, Faculty of Health, Alfred-Herrhausen.Straße 50, 58448, Witten, Germany. Ursula.hahn@uni-wh.de.
2
OcuNet Trial Alliance, Duesseldorf, Friedrichstraße 47, 40217, Duesseldorf, Germany. Ursula.hahn@uni-wh.de.
3
Institute for Medical Biometry and Epidemiology, Witten/Herdecke University, Faculty of Health, Alfred-Herrhausen.Straße 50, 58448, Witten, Germany.
4
Augen-Zentrum-Nordwest, Domhof 15, 48683, Ahaus, Germany.
5
Augenzentrum am St. Franziskus-Hospital, Muenster, Hohenzollernring 74, 48145, Muenster, Germany.

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.

KEYWORDS:

Capsular tension ring; Misalignment; Rotation; Toric intraocular lens

PMID:
31286913
PMCID:
PMC6615103
DOI:
10.1186/s12886-019-1147-5
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for BioMed Central Icon for PubMed Central
Loading ...
Support Center