Predicting the Lens Capsular Bag Size Using Pre-operative Biometry

NCT05578339 | Completed

• 1 other identifier: Capsular bag size
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract Senile

Keywords

capsular bag

Outcome Measures

Primary Outcomes (1)

• Capsular bag size

  • Prediction of the size of the post-operative capsular bag diameter using pre-operative optical biometry (lens thickness, lens shape, anterior chamber depth, axial eye length and angle-to-angle distance)

  2 months

Study Arms (1)

Capsular bag size

OTHER

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.

Device: Biometry

Interventions

Biometry 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).

Capsular bag size

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Parameters that influence the capsular bag stability (pseudoexfoliation syndrome, St. p. severe eye trauma, Phakodonesis)

Sponsors & Collaborators

• Vienna Institute for Research in Ocular Surgery: lead

Study Sites (1)

Hanusch Hospital, Department of Ophthalmology

Vienna, 1140, Austria

Location

MeSH Terms

Interventions

Biometry

Intervention Hierarchy (Ancestors)

Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of department of Ophthalmology, Professor, Principal Investigator, MBA

Study Record Dates

• First Submitted: January 30, 2022
• First Posted: October 13, 2022
• Study Start: May 1, 2020
• Primary Completion: August 30, 2021
• Study Completion: December 20, 2021
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)