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Status unknownNCT03751215Updated Apr 19, 2019

Anterior Chamber Depth Variability Between Two Lenses With Different Materials

An interventional study of Cataract surgery in Cataract, sponsored by Prim. Prof. Dr. Oliver Findl, MBA. Status unknown at 1 site in Austria. Open to participants aged 21 Years to 105 Years. Per ClinicalTrials.gov, last updated 2019-04-19.

Sponsored by Prim. Prof. Dr. Oliver Findl, MBA · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
21 Years to 105 Years
Sex
All
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Study summary

Compare the change of the Anterior chamber depth (ACD) variability between the Clareon and the AcrySof Intraocular lens (IOL) after implantation over 6 months.

Read the detailed description

Patients undergoing cataract surgery are often otherwise healthy and active with their only restriction being reduced visual quality. Within the past few years, intraocular lenses (IOLs) have been improved to fulfill the needs of these patients. Nowadays efforts are aiming for the enhancement of the patient vision and his subjective satisfaction postoperative.

One of the best ways to accomplish this is to have a perfect intraocular lens (IOL) power calculation. However, the best calculation can't help if the implanted intraocular lens (IOL) changes its position after implantation.

It should be considered that an anterior chamber depth (ACD) shift, decentration, tilt or rotation of an IOL could result in a reduction in visual quality. For an aspherical IOL, for instance, it is essential not to be decentrated and tilted more than 0.4 mm 2 (0.8 mm 3) and 7° 2 (10° 3), respectively. Otherwise it will be outperformed by a spherical IOL. The estimation of the post-operative intraocular lens (IOL) position and therefore the estimated anterior chamber depth (ACD) is presently the main source of error (35% 4 to 42% 5) in IOL power calculation and therefore for the refractive outcome of the patients after cataract surgery. Presently the pre-operatively measured ACD is taken into account for several IOL power calculation formulas, such as the Haigis formula, the Holladay II formula and the Olsen formula.

To manage a better outcome an IOL with less postoperative influence of the anterior chamber depth (ACD) is very important. To accomplish a smaller deviation after the operation of the anterior chamber depth (ACD) the haptic and the material of the lens is very important. The change of the anterior chamber depth (ACD) after cataract surgery can be easily measured by instruments like the IOL-Master 700, AC-Master and Lenstar. It must be considered that every person is different and that change of the anterior chamber depth (ACD) in different eyes can cause high measurement errors. The changes in two eyes of the same patient help to minimize the error. These can help to achieve a better outcome for future patients.

The hydrophobic acrylate of the Acrysof IOL has been modified to the new material in the Clareon IOL. This study will evaluate whether the new Clareon has non-inferior axial stability to the Acrysof.

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Conditions studied

  • Cataract

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Keywords

  • Cataract
  • Cataract surgery
  • Intraocular lens
03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's planned enrollment of 50 is below the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Prim. Prof. Dr. Oliver Findl, MBA is the lead sponsor of 38 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 105 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age-related cataract in both eyes
  • Scheduled for bilateral cataract surgery
  • Age 21 and older
  • Written informed consent prior to recruitment
  • Visual Acuity > 0.05

Exclusion criteria

Exclusion Criteria:

  • Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)
  • Any ophthalmic abnormality that could compromise visual function or the measurements
  • Presence of potential zonular weakness such as pseudoexfoliation Syndrome, history of ocular trauma, previous ocular surgery.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Monofocal IOL

    Patients will be implanted with two different monofocal lenses (Clareon and AcrySof) during cataract surgery

    Procedure: Cataract surgery

Interventions

  • ProcedureCataract surgery

    During cataract surgery the patient is implanted with the monofocal IOL Clareon in one eye and the monofocal IOL AcrySof in the contralateral eye

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What researchers measure

Primary outcomes

  1. Anterior chamber depth (ACD)

    The change in anterior chamber depth (ACD) before and after cataract surgery will be measured using the IOL Master 700 and compared between the two different IOLs.

    Time frame: 12 months

Secondary outcomes

  1. Distance visual acuity

    Uncorrected and corrected distance visual acuity will be determined using ETDRS-charts in a distance of 4 metres and differences in refraction will be compared between the two IOLs.

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Vienna Institute for Research in Ocular Surgery (VIROS)
    Vienna, 1140, Austria
    Recruiting
08

References and documents

Publications

  • Ullrich M, Ruiss M, Hienert J, Pilwachs C, Fisus AD, Georgiev S, Hirnschall N, Findl O. Anterior chamber depth variability between 2 hydrophobic acrylic 1-piece intraocular lenses: randomized trial. J Cataract Refract Surg. 2021 Nov 1;47(11):1460-1465. doi: 10.1097/j.jcrs.0000000000000668. PubMed 33929807 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03751215
Lead sponsor
Prim. Prof. Dr. Oliver Findl, MBA
Responsible party
Prim. Prof. Dr. Oliver Findl, MBA (Principal Investigator, Vienna Institute for Research in Ocular Surgery) — Sponsor-investigator
First posted
Nov 23, 2018
Start date
Oct 1, 2018
Primary completion
Dec 1, 2019 (estimated)
Completion
Dec 1, 2019 (estimated)
Last update
Apr 19, 2019

Study contacts

Julius Hienert, MD
Contact
office@viros.at
01/ 91021/ 57564
Manuel Ruiß, MSc.
Contact
office@viros.at
01/ 91021/ 57564

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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