Pseudo Exfoliation SyndromePXFNCT01255995
Natural History of IOL in Pseudo Exfoliation Syndrome
An observational study of Pseudo Exfoliation Syndrome, run by Aurolab at 4 sites in India.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pseudo Exfoliation Syndrome
- What is being tested?
- Capsular Tension Ring
- Type of treatment
- Medical device
- How many people
- 1,500 participants
- Where
- 4 sitesIndia
- Study dates
- Dec 2010to May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: PXF subjects with or without glaucoma who require cataract surgery. Controls without PXF who require cataract surgery
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
India4 sites
Aravind Eye Hospital
Coimbatore, Tamil Nadu, 641014
Aravind Eye Hospital
Madurai, Tamil Nadu, 625020
Aravind Eye Hospital
Pondicherry, Tamil Nadu, 605 007
Aravind Eye Hospital
Tirunelveli, Tamil Nadu, 627001
About this study
Official title: 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
Read the 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.
- Conditions
- Pseudo Exfoliation Syndrome
- Being tested
- Capsular Tension Ring
- Keywords
- PXF
- Medical subject headings
- Exfoliation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsular Tension RingDevice
Also called CTR
Capsular Tension Ring
| Study group | Role | What they receive |
|---|---|---|
| Control Patients | Controls without PXF who require cataract surgery | |
| Pseudo Exfoliation patients | PXF subjects with or without glaucoma who require cataract surgery Receives: Device: Capsular Tension Ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOL Centration / IOL Stability
Measured: 10th Year
Secondary outcomes (4)
Visual Acuity
Measured: 10th Year
Anterior capsular fibrosis/phimosis
Measured: 10th Year
New onset of phacodonesis
Measured: 10th Year
Development or worsening of glaucoma
Measured: 10th Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2021 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudo Exfoliation SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aurolab
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haripriya Aravind, MS, Principal investigator, Aravind Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255995
- Sponsor's protocol ID
- 2PR2240936
- Acronym
- PXF
- Status last verified
- Nov 2012
- First submitted
- 2 Dec 2010
- Last updated
- 16 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Natural History of Artificial Intraocular Lenses (IOL) in Eyes With Exfoliation Syndrome
- ClinicalTrials.gov ID
- NCT01255995
- Acronym / sponsor ID
- PXF / 2PR2240936
- Conditions
- Pseudo Exfoliation Syndrome
- Keywords
- PXF
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- AurolabUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2021 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 8 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Patients | – | –Controls without PXF who require cataract surgery |
| Pseudo Exfoliation patients | – | Device: Capsular Tension RingPXF subjects with or without glaucoma who require cataract surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PXF subjects with or without glaucoma who require cataract surgery. Controls without PXF who require cataract surgery
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- Uncontrolled IOP/glaucoma
- History of narrow angles, chronic narrow angle glaucoma
- Any pre-existing clinical zonular dialysis or phacodonesis
- Pseudo uveitis
- One eyed patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capsular Tension RingAlso: CTRCapsular Tension Ring | Device | Pseudo Exfoliation patients |
Primary outcome
IOL Centration / IOL Stability
Time frame: 10th Year
4 secondary outcomes
Visual Acuity
Time frame: 10th Year
Anterior capsular fibrosis/phimosis
Time frame: 10th Year
New onset of phacodonesis
Time frame: 10th Year
Development or worsening of glaucoma
Time frame: 10th Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haripriya Aravind, MS principal investigator
Aravind Eye Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pseudo Exfoliation Syndrome, run by Aurolab at 4 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOL Centration / IOL Stability (time frame: 10th Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2012.