- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01385878
Outcomes Following Phacoemulsification With 1.8 & 2.2mm Incision: Randomized Clinical Trial
Intraoperative Performance & Postoperative Outcomes Following Phacoemulsification With 1.8 & 2.2mm Incision: Randomized Clinical Trial
Cataract surgical techniques have significantly changed in recent years with the widespread adoption of smaller and smaller clear corneal incisions for phacoemulsification. Microincision surgery has many advantages, including reduced surgically induced astigmatism, faster visual recovery, and reduced intra and postoperative inflammation. Curently, microcoaxial phacoemulsification is being performed through 1.8 as well as 2.2 mm incisions. However, there is still a debate as to which is the best absolute incision size for microcoaxial cataract surgery.
The aim of this study is to evaluate incision stability following microcoaxial phacoemulsification performed through 1.8 and 2.2 mm systems, as well as compare intraoperative performance and postoperative outcomes following microcoaxial phacoemulsification performed through these two incision sizes.
Study Overview
Status
Conditions
Detailed Description
Cataract surgical techniques have significantly changed in recent years with the widespread adoption of smaller and smaller clear corneal incisions for phacoemulsification. Microincision surgery has many advantages, including reduced surgically induced astigmatism, faster visual recovery, and reduced intra and postoperative inflammation. In the recent times, microcoaxial phacoemulsification has gained popularity. The main advantage of this newer technique is that it uses the same methods as the conventional method but with smaller incisions. Curently, microcoaxial phacoemulsification is being performed through 1.8 as well as 2.2 mm incisions. However, there is still a debate as to which is the best absolute incision size for microcoaxial cataract surgery.
The aim of this study is to evaluate incision stability following microcoaxial phacoemulsification performed through 1.8 and 2.2 mm systems, as well as compare intraoperative performance and postoperative outcomes following microcoaxial phacoemulsification performed through these two incision sizes.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Abhay R Vasavada, MS,FRCS
- Phone Number: 91-79-27490909
- Email: icirc@abhayvasavada.com
Study Contact Backup
- Name: Vaishali A Vasavada, MS
- Phone Number: 91-79-27492303
- Email: icirc@abhayvasavada.com
Study Locations
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Gujarat
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Ahmedabad, Gujarat, India, 380009
- Recruiting
- Iladevi Cataract & IOL Research Centre
-
Contact:
- Abhay r Vasavada, MS,FRCS
- Email: icirc@abhayvasavada.com
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Principal Investigator:
- Abhay R Vasavada, MS, FRCS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: Uncomplicated age related cataracts, NO grade II III, IV (LOCS III classification)
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Exclusion Criteria:
- Ocular comorbidity, glaucoma, uveitis, shallow anterior chamber, maximal pupillary dilatation <6mm, high myopia (axial length > 25mm), previous ocular trauma or surgery, pseudoexfoliation, traumatic cataract, subluxated cataract
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Phacoemulsification with 1.8mm incision
Microcoaxial phacoemulsification was performed using a 1.8mm clear corneal incision
|
Phacoemulsification through small clear corneal incision
Phacoemulsification through clear corneal incision
Microcoaxial Phacoemulsification through 1.8mm incision
Microcoaxial phacoemulsification through 2.2mm incision
|
Active Comparator: Phacoemulsification with 2.2mm incisi
Microcoaxial phacoemulsificaiton will be performed through 2.2mm incision
|
Phacoemulsification through small clear corneal incision
Phacoemulsification through clear corneal incision
Microcoaxial Phacoemulsification through 1.8mm incision
Microcoaxial phacoemulsification through 2.2mm incision
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ingress of Trypan blue from the Ocular Surface into the Anterior Chamber
Time Frame: Immediately at the end of surgery
|
At end of surgery, stromal hydration of all incisions will be performed.0.0125% trypan blue will be instilled on the conjunctival surface.After 2 minutes, the surface will be irrigated with balanced salt solution.
0.1ml aqeous aspirate will be obtained from the anterior chamber.Concentration of trypan blue in the aspirate will be ascertained by UV visible spectrophotometry.
Log dilutions of concentration of trypan blue will be used for statistical analysis
|
Immediately at the end of surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Surgically Induced Astigmatism
Time Frame: At baseline and 3 months postoperatively
|
At baseline and 3 months postoperatively
|
Corneal Endothelial Cell Loss
Time Frame: Baseline and 3 months postoperatively
|
Baseline and 3 months postoperatively
|
Change in Central Corneal Thickness
Time Frame: Baseline and 1 week
|
Baseline and 1 week
|
Anterior Chamber Inflammation
Time Frame: Baseline and 1 week
|
Baseline and 1 week
|
Anterior Chamber Inflammation
Time Frame: Baseline and 1 month
|
Baseline and 1 month
|
Collaborators and Investigators
Investigators
- Principal Investigator: Abhay R Vasavada, MS, FRCS, Iladevi Cataract and IOL Research Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- ICIRC-1.8 VS 2.2
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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