Prospective Evaluation of the rotational stability of the Ancoris intraocular lens.

Not Applicable

• Conditions: H25.8; H52.2; Other senile cataract; Astigmatism

• Registration Number: DRKS00010912
• Lead Sponsor: PhysIOL SALiège Science Park

Brief Summary

This prospective study was performed to investigate the visual performance, refractive outcomes, and IOL stability of POD T IOLs (PhysIOL, Belgium). Predicted versus achieved refractive outcomes, visual performance at distance as well as rotational stability have been analyzed. The follow-up period was 3 months. All IOL implantations were performed by the investigator Prof. Dr. Burkhard Dick (Universitäts-Augenklinik Bochum, Germany). The study population consists of patients undergoing routine cataract surgery and study patients underwent monocular implantation of POD T IOLs. Overall, the data of 20 eyes were analyzed in this study report. The study endpoints 3 months postoperatively were as follows: - Manifest refraction and predictability - Monocular uncorrected distance visual acuity - Monocular corrected distance visual acuity - Rotational stability - Intraocular pressure - Safety outcomes (adverse events) Data on IOL rotation were limited. Mean absolute IOL rotation (versus baseline 1 day postop) was 1.3±2.1° (n=5) at 1 month and 2.3±0.2° (n=4) at 3 months and secondary repositioning was not required in any case. At 3 months, IOL rotation was =5° in 100% of eyes. The mean refractive cylinder decreased from -2.18±1.19 D (range -4.50 D to -0.75 D) preoperatively to - 0.45±0.31 D (range -1.25 D to 0.00 D) at 3 months. At 3 months, almost all eyes (95%) had a postoperative refractive cylinder of =1.0 D and 80% of eyes had a refractive cylinder of =0.5 D. All eyes (100%) were within =1.25 D of refractive cylinder. The magnitude of the J0 vector significantly decreased postoperatively (p=0.040). The mean J45 vector was close to zero preoperatively and postoperatively. Mean monocular uncorrected distance visual acuity was 0.12±0.13 logMAR and 55% of eyes achieved 20/25 or better. Mean preoperative CDVA increased from 0.31±0.13 logMAR to 0.06±0.11 logMAR and was 20/20 or better in 60% of eyes and 20/25 or better in 80% of eyes. This study confirms the predictability of the refractive correction achieved with the evaluated monofocal toric IOL with 90% of eyes within ±0.5 D and 100% of eyes within ±1.0 D of target SE refraction. No SAE associated with POD T IOL implantation was reported. In one case (5%), a cystoid macular edema occurred (detected at the first postoperative day). The edema was treated with medication and the AE could be resolved after therapy. It can be concluded that cataract surgery with implantation of the monofocal toric POD T IOL was safe and effective in reducing low to moderate preexisting corneal astigmatism and provided good rotational stability and refractive outcomes.

Detailed Description

Not available

Study Timeline

• Study Completion: 2015-01-06
• Study Start: 2016-08-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

•Cataracteous Eyes with no comorbidity
•Regular corneal astigmatism >1 dioptre and <3D determined by an automatic keratometer (regularity determined by the topography of the keratometry).
•Availability, willingness and sufficient cognitive awareness to comply with examination procedures
•Signed informed consent
•>50 years old

Exclusion Criteria

•Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc…)
•Any ocular comorbidity
•History of ocular trauma or prior ocular surgery including refractive procedures
•Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, Marfan’s syndrome)
•Pupil abnormalitis (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determining the rotational stability of the intraocular lens (Ankoris) by photography of the IOL to the visits day 1, month 1 and month 3 with electronic measurement of the axial position.

Secondary Outcome Measures

Name	Time	Method
Measuring the remaining astigmatism after Ankoris implantation compared to the target astigmatism by standard method (refraction) to the visits month 1 and month 3