Predicting the Lens Capsular Bag Size Using Pre-operative Biometry

NCT ID: NCT05578339

Last Updated: 2022-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2021-12-20

Brief Summary

Aim of this study is to assess whether a high-resolution scan of the crystalline lens before surgery may be helpful in predicting post-operative capsule bag diameter.

Detailed Description

Most of the measurement procedures used in this study are non-invasive and all are used in standard routine clinical practice, the benefit/risk ratio appears acceptable.

However, a capsule tension ring will be used. A CTR is not used routinely, usually only in cataract operations in which the lens capsule is not stable enough - in other words, for stabilization. The insertion of the CTR is problem-free in most cases. In extremely rare cases, however, the lens capsule may be injured. And document complications will be collected, report them in a final paper. The CTR used in the study is a standard device and CE-marked device. Studies using CTR showed that it is beneficial in difficult cases.

Gonioscopy after cataract surgery will be performed after 1 week. At this time point the wound is already sealed and there appears to be no increased risk to the patient. In the first study performed in a similar fashion in 1999 gonioscopy was performed one day after surgery.

Aim of this study is to predict the diameter of the capsular bag using pre-operative optical biometry findings.

This is a prospective, observer-blind and monocentric study that includes patients scheduled for cataract surgery. Recruitment will take part on the day of pre-assessment. For each patient only one eye will be included.

In total 50 eyes of 50 patients will be included, of which at least 5 eyes with an axial eye length below 22.5mm and 5 eyes with an axial eye length above 25.0mm.

Conditions

Cataract Senile

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Capsular bag size

Lens thickness, lens shape, anterior chamber depth, axial eye length and angle-to-angle will be used as explanatory variables (independent variables) and the size of the capsular bag will be used as main outcome parameter (dependent variable).

We will perform a multiple linear regression analysis (that allows determination of the overall fit (variance explained) of the model and the relative contribution of each of the predictors to the total variance explaine) between the independent and the dependent variable.

Group Type: OTHER

Biometry

Intervention Type: DEVICE

Lens thickness, lens shape, anterior chamber depth, axial eye length and angle-to-angle will be used as explanatory variables (independent variables) and the size of the capsular bag will be used as main outcome parameter (dependent variable).

Interventions

Biometry

Lens thickness, lens shape, anterior chamber depth, axial eye length and angle-to-angle will be used as explanatory variables (independent variables) and the size of the capsular bag will be used as main outcome parameter (dependent variable).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient scheduled for cataract surgery
• Well dilated pupil at the pre-assessment visit (dilated pupil size at least 6.0mm)
• Age 21 and older
• Pre-operative visual acuity of at least 0.25 Snellen

Exclusion Criteria

• Parameters that influence the capsular bag stability (pseudoexfoliation syndrome, St. p. severe eye trauma, Phakodonesis)
• In women of childbearing age, a pregnancy test will be performed before inclusion into the study.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vienna Institute for Research in Ocular Surgery

OTHER

Sponsor Role: lead

Responsible Party

Prim. Prof. Dr. Oliver Findl, MBA

head of department of Ophthalmology, Professor, Principal Investigator, MBA

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hanusch Hospital, Department of Ophthalmology

Vienna, , Austria

Countries

Austria

Other Identifiers

Capsular bag size

Identifier Type: -

Identifier Source: org_study_id