Natural History of IOL in Pseudo Exfoliation Syndrome (PXF)

November 15, 2012 updated by: Aurolab

The Natural History of Artificial Intraocular Lenses (IOL) in Eyes With Exfoliation Syndrome

  • The purpose of this study is to determine the natural course of IOL in PXF,
  • To demonstrate use of a clinical grading system for PXF,
  • To strategize a way to prevent IOL dislocation, subluxation post operatively,
  • To demonstrate intraoperative and long-term post-operative complications associated with phaco and PXF
  • To suggest evidence-based ways to minimize these complications, by using capsular tension rings (CTR), specific IOL material or size

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Pseudo exfoliation syndrome (PXF) is a generalized degenerative microfibrillopathy that primarily is manifested with deposits of exfoliative material present on the anterior capsule of the crystalline lens, zonules, papillary margin of the iris, corneal endothelium, ciliary body and the trabecular meshwork. The build of this exfoliative material causes microscopic changes of the zonules and their attachments, causing a weakening of the zonules. These clinical findings have implications not only for cataract surgery, as association of lens opacities with exfoliation syndrome is well documented but also for glaucoma, with exfoliative glaucoma being the most common cause for secondary open angle glaucoma in the world.In patients with exfoliation syndrome, small pupil and phacodonesis, comparison between extra capsular cataract extraction and small incision cataract surgery revealed better best corrected visual acuity and fewer intra and post operative complications with the smaller incision for phacoemulsification. The capsular tension rings (CTR) implanted prior to phacoemulsification reduced intraoperative zonular dialysis, increased the rate of capsular IOL fixation, and improved uncorrected visual acuity. Either the degree of lens change the stage of PXF, or the type of IOL might influence long term outcome in PXF associated with cataract surgery:The postoperative course of those with either more advanced cataract or with more advanced PXF may be different than those who have surgery with less cataract our and/or degree of PXF. The stage of PXF alone at the time of cataract surgery may influence outcome. Once PXF identified, surgery performed at an earlier stage of cataract with a softer lens in XFS results in fewer long term problems following phacoemulsification. A standardized way of clinically measuring/monitoring XFS is helpful during large clinical studies Specific intraocular lens design should be considered when scheduling phacoemulsification in patients with PXF.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1500

Contacts and Locations

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

Study Locations

  • India
    • Tamil Nadu
      • Coimbatore, Tamil Nadu, India, 641014
        • Aravind Eye Hospital
      • Madurai, Tamil Nadu, India, 625020
        • Aravind Eye Hospital
      • Pondicherry, Tamil Nadu, India, 605 007
        • Aravind Eye Hospital
      • Tirunelveli, Tamil Nadu, India, 627001
        • Aravind Eye Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

PXF subjects with or without glaucoma who require cataract surgery. Controls without PXF who require cataract surgery

Description

Inclusion Criteria:

  • Age 40-75
  • PXF with or without secondary open-angle glaucoma who present with cataract and willing to undergo phacoemulsification with IOL
  • Nuclear sclerosis with LOCS III grade and above
  • Pupil size more than 4mm on dilatation
  • Endothelial cell count >1,500
  • No visible phacodonesis

Exclusion Criteria:

  • Uncontrolled IOP/glaucoma
  • History of narrow angles, chronic narrow angle glaucoma
  • Any pre-existing clinical zonular dialysis or phacodonesis
  • Pseudo uveitis
  • One eyed patients
  • Cardiac pathology
  • Uncontrolled diabetes, hypertension & severe asthma
  • Obviously debilitated patients
  • Traumatic cataract
  • Complicated cataract
  • Congenital cataract
  • Drug induced cataract
  • Shallow anterior Chamber
  • Amblyopia
  • Dense posterior polar cataract
  • Corneal pathology
  • Retinal pathology
  • RAPD
  • Severe visual field defect (MD->12.0dB)
  • Diabetic retinopathy
  • Combined Surgery

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Control Patients
Controls without PXF who require cataract surgery
Pseudo Exfoliation patients
PXF subjects with or without glaucoma who require cataract surgery
Device: Capsular Tension Ring
Capsular Tension Ring
Other Names:
  • CTR

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
IOL Centration / IOL Stability
Time Frame: 10th Year
10th Year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Visual Acuity
Time Frame: 10th Year
10th Year
Anterior capsular fibrosis/phimosis
Time Frame: 10th Year
10th Year
New onset of phacodonesis
Time Frame: 10th Year
10th Year
Development or worsening of glaucoma
Time Frame: 10th Year
10th Year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aurolab

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Haripriya Aravind, MS, Aravind Eye Hospital

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2010

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 8, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 16, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2PR2240936

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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