Cystoid Macular Edema Following Cataract SurgeryPhase 4NCT01385852
CME With Different Fluidic Parameters
A Phase 4 study testing microcoaxial phacoemulsification in people with Cystoid Macular Edema Following Cataract Surgery, run by Iladevi Cataract and IOL Research Center at 1 site in India.
Trial summary
Understanding and modulating fluid parameters is an important, but often overlooked aspect of phacoemulsification. In a previous study we compared the impact of using high fluid parameters versus low fluidic parameters on real-time IOP measured during phacoemulsification. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystoid Macular Edema Following Cataract Surgery
- What is being tested?
- microcoaxial phacoemulsification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIndia
- Study dates
- May 2010to Aug 2011
- Phase
- Phase 4
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Uncomplicated, Age-related cataract.
- Nuclear sclerosis: upto grade 3
- Age: 40-70 years
- Axial length: 21.5 mm to 24.5 mm
Who cannot join
- Diabetes mellitus
- Co-existing ocular disease- uveitis, glaucoma, PEX
- Pre-existing macular pathology (eg.ARMD)
- Previously operated eyes
- Under treatment with Topical or systemic steroids / NSAID's
- Intraoperative complications- PCR, Descemet's detachment, uveal trauma
- Post operative complications - severe inflammation (>grade 3), rise in IOP
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Different Fluidic Parameters on Development of Cystoid Macular Edema Following Phacoemulsification
Understanding and modulating fluid parameters is an important, but often overlooked aspect of phacoemulsification. In a previous study we compared the impact of using high fluid parameters versus low fluidic parameters on real-time IOP measured during phacoemulsification. The investigators found that using high parameters resulted in a higher absolute rise in IOP as well as higher fluctuations in the IOP when compared to low parameters. Clinically these higher fluctuations in IOP would translate in a higher chamber instability. Based on the results of this study, the investigators decided to take it further and study the impact of using high parameters (and thus, higher chamber instability) on macular edema and thickness following surgery, in an otherwise uncomplicated surgery.
Higher fluid parameters during phacoemulsification predisposes the eye to increased macular thickness
Read the detailed description
Several studies have shown the adverse impact of an increase in the IOP and IOP fluctuations that occur during anterior segment intervention on the posterior segment structures. In human volunteers with each incremental increase in IOP the systolic and diastolic flow velocities in the short posterior ciliary arteries decreased linearly. This implies that the normal healthy eye is not able to autoregulate to maintain posterior ciliary artery blood flow velocities in response to acute large elevations in IOP. Vascular insufficiency due to abnormal autoregulation has been proposed as a major factor in the development of glaucoma. 1
It has been postulated that IOP elevation during the LASIK procedure causes mechanical stress which may induce tangential stress on the posterior segment.2, 3 Some studies have reported that the increase in IOP damages the retinal ganglion cells causing visual field defects. Also sudden increases in IOP, although well tolerated may induce changes in the peripheral retina.4,5,6
Several reports propose the occurrence of macular hole, lacquer cracks and choroidal neovascular membranes following the LASIK procedure. 3 It has been observed that the rapidly fluctuating pressure variations may be detrimental, particularly in susceptible persons with compromised ocular blood flow. Rapid IOP changes across a 30-mm Hg range would be predicted to influence posterior segment blood vessels.
In a previous study we compared the impact of using high fluid parameters versus low fluidic parameters on real-time IOP measured during phacoemulsification. We found that using high parameters resulted in a higher absolute rise in IOP as well as higher fluctuations in the IOP when compared to low parameters. Clinically these higher fluctuations in IOP would translate in a higher chamber instability.
We hypothesize that although transient, the increased IOP that occurs during phacoemulsification when using high parameters could cause mechanical stress on the eye. These higher fluid parameters during phacoemulsification can predispose the eye to increased macular thickness.
To the best of our knowledge there are no published data on impact of IOP changes and fluctuation that are induced during cataract surgery on the macula. To investigate this further, we decided to study the impact of using high parameters (and thus, higher chamber instability) on macular thickness following surgery, in an otherwise uncomplicated surgery.
- Being tested
- microcoaxial phacoemulsification
- Keywords
- CME, OCT, Optical coherence tomography, macular thickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microcoaxial phacoemulsificationProcedure or surgery
Also called phacoemulsification, small incision cataract surgery
conventional longitudinal ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Longitudinal U/S - low fluidic | Active comparator | ASPIRATION FLOW RATE - 25 CC/MIN, BOTTLE HEIGHT - 90 CMS, LONGITUDINAL ULTRASOUND Receives: Procedure: microcoaxial phacoemulsification |
| Torsional U/S - low fluidic | Active comparator | ASPIRATION FLOW RATE - 25 CC/MIN, BOTTLE HEIGHT - 90 CMS, TORSIONAL ULTRASOUND Receives: Procedure: microcoaxial phacoemulsification |
| Longitudinal U/S - high fluidic | Active comparator | ASPIRATION FLOW RATE - 40 CC/MIN, BOTTLE HEIGHT - 110 CMS, LONGITUDINAL ULTRASOUND Receives: Procedure: microcoaxial phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
cystoid macular edema (CME)
A > or = 30% increase in baseline central foveal thickness measaured by anterior segment OCT will be defined as having CME.
Measured: 3 months
Secondary outcomes (5)
macular thickness
macular thickness measured in 3 zones using the anterior segment OCT
Measured: 1, 3 months
central corneal thickness (CCT)
CCT will be measured on the ultrasound pachymeter by a single experienced observer
Measured: first post-operative day,
endothelial cell loss
Endothelial cell loss will be measured using a specular microscope in the central area by a single technician
Measured: 6 months post-operative
anterior chamber inflammation
it will be assessed on the slit lamp examination by a single experienced observer using the Hogan's criteria
Measured: 1 months
CORRECTED DISTANCE VISUAL ACUITY (CDVA)
visual acuity (VA) of 20/40 or worse was defined as "clinically significant"
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study startMay 2010
- Primary completionFeb 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cystoid Macular Edema Following Cataract SurgeryStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iladevi Cataract and IOL Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abhay R. Vasavada, Iladevi Cataract and IOL Research Center
- Investigators
- ABHAY R VASAVADA, MS, FRCS, Principal investigator, ILADEVI CATARACT AND RESEARCH CENTER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385852
- Sponsor's protocol ID
- 10-005
- Status last verified
- Jun 2012
- First submitted
- 28 Jun 2011
- Last updated
- 6 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim SJ, Belair ML, Bressler NM, Dunn JP, Thorne JE, Kedhar SR, Jabs DA. A method of reporting macular edema after cataract surgery using optical coherence tomography. Retina. 2008 Jun;28(6):870-6. doi: 10.1097/IAE.0b013e318169d04e.
PubMed 18536605Cagini C, Fiore T, Iaccheri B, Piccinelli F, Ricci MA, Fruttini D. Macular thickness measured by optical coherence tomography in a healthy population before and after uncomplicated cataract phacoemulsification surgery. Curr Eye Res. 2009 Dec;34(12):1036-41. doi: 10.3109/02713680903288937.
PubMed 19958122Belair ML, Kim SJ, Thorne JE, Dunn JP, Kedhar SR, Brown DM, Jabs DA. Incidence of cystoid macular edema after cataract surgery in patients with and without uveitis using optical coherence tomography. Am J Ophthalmol. 2009 Jul;148(1):128-35.e2. doi: 10.1016/j.ajo.2009.02.029. Epub 2009 Apr 29.
PubMed 19403110Lee YC, Chung FL, Chen CC. Intraocular pressure and foveal thickness after phacoemulsification. Am J Ophthalmol. 2007 Aug;144(2):203-208. doi: 10.1016/j.ajo.2007.04.020. Epub 2007 May 30.
PubMed 17540324Kim SJ, Equi R, Bressler NM. Analysis of macular edema after cataract surgery in patients with diabetes using optical coherence tomography. Ophthalmology. 2007 May;114(5):881-9. doi: 10.1016/j.ophtha.2006.08.053. Epub 2007 Feb 1.
PubMed 17275910Perente I, Utine CA, Ozturker C, Cakir M, Kaya V, Eren H, Kapran Z, Yilmaz OF. Evaluation of macular changes after uncomplicated phacoemulsification surgery by optical coherence tomography. Curr Eye Res. 2007 Mar;32(3):241-7. doi: 10.1080/02713680601160610.
PubMed 17453944Biro Z, Balla Z, Kovacs B. Change of foveal and perifoveal thickness measured by OCT after phacoemulsification and IOL implantation. Eye (Lond). 2008 Jan;22(1):8-12. doi: 10.1038/sj.eye.6702460. Epub 2006 Jun 2.
PubMed 16751754
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Different Fluidic Parameters on Development of Cystoid Macular Edema Following Phacoemulsification
- ClinicalTrials.gov ID
- NCT01385852
- Acronym / sponsor ID
- 10-005
- Keywords
- CME, OCT, Optical coherence tomography, macular thickness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Iladevi Cataract and IOL Research CenterUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 30 Jun 2011 (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.
Understanding and modulating fluid parameters is an important, but often overlooked aspect of phacoemulsification. In a previous study we compared the impact of using high fluid parameters versus low fluidic parameters on real-time IOP measured during phacoemulsification. The investigators found that using high parameters resulted in a higher absolute rise in IOP as well as higher fluctuations in the IOP when compared to low parameters. Clinically these higher fluctuations in IOP would translate in a higher chamber instability. Based on the results of this study, the investigators decided to take it further and study the impact of using high parameters (and thus, higher chamber instability) on macular edema and thickness following surgery, in an otherwise uncomplicated surgery.
Higher fluid parameters during phacoemulsification predisposes the eye to increased macular thickness
Detailed description
Several studies have shown the adverse impact of an increase in the IOP and IOP fluctuations that occur during anterior segment intervention on the posterior segment structures. In human volunteers with each incremental increase in IOP the systolic and diastolic flow velocities in the short posterior ciliary arteries decreased linearly. This implies that the normal healthy eye is not able to autoregulate to maintain posterior ciliary artery blood flow velocities in response to acute large elevations in IOP. Vascular insufficiency due to abnormal autoregulation has been proposed as a major factor in the development of glaucoma. 1
It has been postulated that IOP elevation during the LASIK procedure causes mechanical stress which may induce tangential stress on the posterior segment.2, 3 Some studies have reported that the increase in IOP damages the retinal ganglion cells causing visual field defects. Also sudden increases in IOP, although well tolerated may induce changes in the peripheral retina.4,5,6
Several reports propose the occurrence of macular hole, lacquer cracks and choroidal neovascular membranes following the LASIK procedure. 3 It has been observed that the rapidly fluctuating pressure variations may be detrimental, particularly in susceptible persons with compromised ocular blood flow. Rapid IOP changes across a 30-mm Hg range would be predicted to influence posterior segment blood vessels.
In a previous study we compared the impact of using high fluid parameters versus low fluidic parameters on real-time IOP measured during phacoemulsification. We found that using high parameters resulted in a higher absolute rise in IOP as well as higher fluctuations in the IOP when compared to low parameters. Clinically these higher fluctuations in IOP would translate in a higher chamber instability.
We hypothesize that although transient, the increased IOP that occurs during phacoemulsification when using high parameters could cause mechanical stress on the eye. These higher fluid parameters during phacoemulsification can predispose the eye to increased macular thickness.
To the best of our knowledge there are no published data on impact of IOP changes and fluctuation that are induced during cataract surgery on the macula. To investigate this further, we decided to study the impact of using high parameters (and thus, higher chamber instability) on macular thickness following surgery, in an otherwise uncomplicated surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Longitudinal U/S - low fluidic | Active comparator | Procedure: microcoaxial phacoemulsificationASPIRATION FLOW RATE - 25 CC/MIN, BOTTLE HEIGHT - 90 CMS, LONGITUDINAL ULTRASOUND |
| Torsional U/S - low fluidic | Active comparator | Procedure: microcoaxial phacoemulsificationASPIRATION FLOW RATE - 25 CC/MIN, BOTTLE HEIGHT - 90 CMS, TORSIONAL ULTRASOUND |
| Longitudinal U/S - high fluidic | Active comparator | Procedure: microcoaxial phacoemulsificationASPIRATION FLOW RATE - 40 CC/MIN, BOTTLE HEIGHT - 110 CMS, LONGITUDINAL ULTRASOUND |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Uncomplicated, Age-related cataract.
- Nuclear sclerosis: upto grade 3
- Age: 40-70 years
- Axial length: 21.5 mm to 24.5 mm
Key exclusion criteria (7 listed)
- Diabetes mellitus
- Co-existing ocular disease- uveitis, glaucoma, PEX
- Pre-existing macular pathology (eg.ARMD)
- Previously operated eyes
- Under treatment with Topical or systemic steroids / NSAID's
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 |
|---|---|---|
| microcoaxial phacoemulsificationAlso: phacoemulsification, small incision cataract surgeryconventional longitudinal ultrasound | Procedure or surgery | Longitudinal U/S - high fluidic, Longitudinal U/S - low fluidic, Torsional U/S - low fluidic |
Primary outcome
cystoid macular edema (CME)
Time frame: 3 months
A > or = 30% increase in baseline central foveal thickness measaured by anterior segment OCT will be defined as having CME.
5 secondary outcomes
macular thickness
Time frame: 1, 3 months
central corneal thickness (CCT)
Time frame: first post-operative day,
endothelial cell loss
Time frame: 6 months post-operative
anterior chamber inflammation
Time frame: 1 months
CORRECTED DISTANCE VISUAL ACUITY (CDVA)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2012.
- Results publication: PubMed 18536605Kim SJ, Belair ML, Bressler NM, Dunn JP, Thorne JE, Kedhar SR, Jabs DA. A method of reporting macular edema after cataract surgery using optical coherence tomography. Retina. 2008 Jun;28(6):870-6. doi: 10.1097/IAE.0b013e318169d04e.
- Results publication: PubMed 19958122Cagini C, Fiore T, Iaccheri B, Piccinelli F, Ricci MA, Fruttini D. Macular thickness measured by optical coherence tomography in a healthy population before and after uncomplicated cataract phacoemulsification surgery. Curr Eye Res. 2009 Dec;34(12):1036-41. doi: 10.3109/02713680903288937.
- Results publication: PubMed 19403110Belair ML, Kim SJ, Thorne JE, Dunn JP, Kedhar SR, Brown DM, Jabs DA. Incidence of cystoid macular edema after cataract surgery in patients with and without uveitis using optical coherence tomography. Am J Ophthalmol. 2009 Jul;148(1):128-35.e2. doi: 10.1016/j.ajo.2009.02.029. Epub 2009 Apr 29.
- Results publication: PubMed 17540324Lee YC, Chung FL, Chen CC. Intraocular pressure and foveal thickness after phacoemulsification. Am J Ophthalmol. 2007 Aug;144(2):203-208. doi: 10.1016/j.ajo.2007.04.020. Epub 2007 May 30.
- Results publication: PubMed 17275910Kim SJ, Equi R, Bressler NM. Analysis of macular edema after cataract surgery in patients with diabetes using optical coherence tomography. Ophthalmology. 2007 May;114(5):881-9. doi: 10.1016/j.ophtha.2006.08.053. Epub 2007 Feb 1.
- Results publication: PubMed 17453944Perente I, Utine CA, Ozturker C, Cakir M, Kaya V, Eren H, Kapran Z, Yilmaz OF. Evaluation of macular changes after uncomplicated phacoemulsification surgery by optical coherence tomography. Curr Eye Res. 2007 Mar;32(3):241-7. doi: 10.1080/02713680601160610.
- Results publication: PubMed 16751754Biro Z, Balla Z, Kovacs B. Change of foveal and perifoveal thickness measured by OCT after phacoemulsification and IOL implantation. Eye (Lond). 2008 Jan;22(1):8-12. doi: 10.1038/sj.eye.6702460. Epub 2006 Jun 2.
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.
ABHAY R VASAVADA, MS, FRCS principal investigator
ILADEVI CATARACT AND RESEARCH CENTER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing microcoaxial phacoemulsification in people with Cystoid Macular Edema Following Cataract Surgery, run by Iladevi Cataract and IOL Research Center at 1 site 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 6 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
cystoid macular edema (CME) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01385852, which also lists 7 linked publications.
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 6 Jun 2012.