- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01385852
CME With Different Fluidic Parameters
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
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Gujarat
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Ahmedabad, Gujarat, India, 380013
- Raghudeep Eye Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Uncomplicated, Age-related cataract.
- Nuclear sclerosis: upto grade 3
- Age: 40-70 years
- Axial length: 21.5 mm to 24.5 mm
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Longitudinal U/S - low fluidic
ASPIRATION FLOW RATE - 25 CC/MIN, BOTTLE HEIGHT - 90 CMS, LONGITUDINAL ULTRASOUND
|
conventional longitudinal ultrasound
Other Names:
|
Active Comparator: Torsional U/S - low fluidic
ASPIRATION FLOW RATE - 25 CC/MIN, BOTTLE HEIGHT - 90 CMS, TORSIONAL ULTRASOUND
|
conventional longitudinal ultrasound
Other Names:
|
Active Comparator: Longitudinal U/S - high fluidic
ASPIRATION FLOW RATE - 40 CC/MIN, BOTTLE HEIGHT - 110 CMS, LONGITUDINAL ULTRASOUND
|
conventional longitudinal ultrasound
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
macular thickness
Time Frame: 1, 3 months
|
macular thickness measured in 3 zones using the anterior segment OCT
|
1, 3 months
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central corneal thickness (CCT)
Time Frame: first post-operative day,
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CCT will be measured on the ultrasound pachymeter by a single experienced observer
|
first post-operative day,
|
endothelial cell loss
Time Frame: 6 months post-operative
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Endothelial cell loss will be measured using a specular microscope in the central area by a single technician
|
6 months post-operative
|
anterior chamber inflammation
Time Frame: 1 months
|
it will be assessed on the slit lamp examination by a single experienced observer using the Hogan's criteria
|
1 months
|
CORRECTED DISTANCE VISUAL ACUITY (CDVA)
Time Frame: 3 months
|
visual acuity (VA) of 20/40 or worse was defined as "clinically significant"
|
3 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: ABHAY R VASAVADA, MS, FRCS, ILADEVI CATARACT AND RESEARCH CENTER
Publications and helpful links
General 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.
- Cagini 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.
- Belair 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.
- Lee 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.
- Kim 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.
- Perente 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.
- Biro 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-005
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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