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Anterior Chamber Depth Variability Between Two Lenses With Different Materials

Sponsor
Prim. Prof. Dr. Oliver Findl, MBA (Other)
Overall Status
Unknown status
CT.gov ID
NCT03751215
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
14
Anticipated Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Cataract surgery
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Anterior Chamber Depth (ACD) Variability Between the Clareon and Acrysof IOL: a Randomised Trial
Actual Study Start Date :
Oct 1, 2018
Anticipated Primary Completion Date :
Dec 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Monofocal IOL

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

Procedure: Cataract 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

Outcome Measures

Primary Outcome Measures

  1. Anterior chamber depth (ACD) [12 months]

    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.

Secondary Outcome Measures

  1. Distance visual acuity [12 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 105 Years
Sexes Eligible for Study:
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:

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vienna Institute for Research in Ocular Surgery (VIROS) Vienna Austria 1140

Sponsors and Collaborators

  • Prim. Prof. Dr. Oliver Findl, MBA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prim. Prof. Dr. Oliver Findl, MBA, Principal Investigator, Vienna Institute for Research in Ocular Surgery
ClinicalTrials.gov Identifier:
NCT03751215
Other Study ID Numbers:
  • Clareon
First Posted:
Nov 23, 2018
Last Update Posted:
Apr 19, 2019
Last Verified:
Apr 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Prim. Prof. Dr. Oliver Findl, MBA, Principal Investigator, Vienna Institute for Research in Ocular Surgery
Cataract
Cataract surgery
Intraocular lens
Additional relevant MeSH terms:
Cataract

Study Results

No Results Posted as of Apr 19, 2019