Anterior Chamber Versus Scleral Fixated Intraocular Lens: Long-term Vision and Safety Outcomes

November 23, 2023 updated by: Dr. Peter Kertes, Sunnybrook Health Sciences Centre
This is a prospective comparative non-randomized cohort study to understand the long-term vision outcomes, safety, and stability of anterior chamber intraocular lenses (AC IOLs) vs. scleral-fixated intraocular lenses (SF IOLs).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

On the pre-operative visit, specular microscopy, biometry, applanation tonometry and ocular coherence tomography (OCT) will be performed. The patient will then undergo treatment as per surgeon's discussion/ decision with the patient for implantation of an AC-IOL or SF-IOL. Participation in the study will not impact the management plan in any way. Specular microscopy will be performed wit the CellChek XL (Konan Medical, Irvine, CA). Biometry will be performed with the IOLMASTER (Carl Ziess Meditec, Jena, Germany), and anterior segment and macular OCT will be performed with the Cirrus-HD OCT (Carl Zeiss Metidec, Jena, Germany). EC count, OCT (macula and anterior segment) and specular microscopy will be performed at baseline, week 1, month 1, month 6, 12 and 24.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All patients who are planned to undergo surgical implantation of an anterior chamber intraocular lens or a scleral-fixated IOL who present to the study investigators as part of the vitreoretinal surgery team at Sunnybrook Hospital or the Toronto Western Hospital.

Description

Inclusion Criteria:

  1. Patients who are undergoing AC IOL or SF IOL implantation for any reason (including but not limited to aphakia, posterior capsular rupture, primary or secondary lens dislocation/ subluxation or IOL exchange).
  2. Patients on whom imaging (specular microscopy, biometry and OCT) can be performed without delaying their treatment (i.e. based on availability of operator).
  3. Decision makers able to provide informed consent.

Exclusion Criteria:

  1. Inability to obtain adequate imaging, in the form of specular microscopy and OCT data at baseline.
  2. Patients unable to attend follow-up visits.
  3. Patients who have had a corneal transplant prior to secondary IOL implantation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intraocular lens implantation: AC IOL

Patients who are scheduled to undergo AC IOL (anterior chamber intraocular lens) implantation for any of the following indications:

  • primary or secondary aphakia
  • primary or secondary lens subluxation or dislocation
Device: Intraocular lens implantation
Implantation of an intraocular lens using either an anterior chamber IOL or a scleral fixated IOL using the modified Yamane technique.
Other Names:
  • IOL implantation
Intraocular lens implantation: SF IOL

Patients who are scheduled to undergo SF IOL (scleral fixated intraocular lens) implantation for any of the following indications:

  • primary or secondary aphakia
  • primary or secondary lens subluxation or dislocation
Device: Intraocular lens implantation
Implantation of an intraocular lens using either an anterior chamber IOL or a scleral fixated IOL using the modified Yamane technique.
Other Names:
  • IOL implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelial cell loss
Time Frame: Pre-operative (baseline) and 24 weeks post-operatively.
Change in endothelial cell count from baseline compared to 24 months post-operatively.
Pre-operative (baseline) and 24 weeks post-operatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corrected distance visual acuity (CDVA)
Time Frame: Pre-operative (baseline), week 1, months 1, 6, 12 and 24 post-operatively.
CDVA will be measured using a standardized Early Treatment Diabetic Retinopathy Study (ETDRS) chart
Pre-operative (baseline), week 1, months 1, 6, 12 and 24 post-operatively.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary adverse events (SAE's)
Time Frame: Pre-operative (baseline), week 1, months 1, 6, 12 and 24 post-operatively.
Occurrence of cystoid macular edema (CME), retinal detachment, UGH syndrome, vitreous or choroidal hemorrhage, lens subluxation/ dislocation, glaucoma, uveitis, etc.
Pre-operative (baseline), week 1, months 1, 6, 12 and 24 post-operatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Investigators

  • Principal Investigator: Peter Kertes, MD, Sunnybrook Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

January 30, 2025

Study Registration Dates

First Submitted

August 26, 2019

First Submitted That Met QC Criteria

August 27, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 23, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00046460

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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