Outcomes Following Phacoemulsification With 1.8 & 2.2mm Incision: Randomized Clinical Trial
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cataract |
Procedure: Microcoaxial Phacoemulsification |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Intraoperative Performance & Postoperative Outcomes Following Phacoemulsification With 1.8 & 2.2mm Incision: Randomized Clinical Trial |
- Ingress of Trypan blue from the Ocular Surface into the Anterior Chamber [ Time Frame: Immediately at the end of surgery ] [ Designated as safety issue: No ]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
- Surgically Induced Astigmatism [ Time Frame: At baseline and 3 months postoperatively ] [ Designated as safety issue: No ]
- Corneal Endothelial Cell Loss [ Time Frame: Baseline and 3 months postoperatively ] [ Designated as safety issue: No ]
- Change in Central Corneal Thickness [ Time Frame: Baseline and 1 week ] [ Designated as safety issue: No ]
- Anterior Chamber Inflammation [ Time Frame: Baseline and 1 week ] [ Designated as safety issue: No ]
- Anterior Chamber Inflammation [ Time Frame: Baseline and 1 month ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 110 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Phacoemulsification with 1.8mm incision
Microcoaxial phacoemulsification was performed using a 1.8mm clear corneal incision
|
Procedure: Microcoaxial Phacoemulsification
Phacoemulsification through small clear corneal incision
Procedure: Microcoaxial Phacoemulsification
Phacoemulsification through clear corneal incision
Procedure: Microcoaxial Phacoemulsification
Microcoaxial Phacoemulsification through 1.8mm incision
|
|
Active Comparator: Phacoemulsification with 2.2mm incisi
Microcoaxial phacoemulsificaiton will be performed through 2.2mm incision
|
Procedure: Microcoaxial Phacoemulsification
Phacoemulsification through small clear corneal incision
Procedure: Microcoaxial Phacoemulsification
Phacoemulsification through clear corneal incision
Procedure: Microcoaxial Phacoemulsification
Microcoaxial Phacoemulsification through 1.8mm incision
Procedure: Microcoaxial Phacoemulsification
Microcoaxial phacoemulsification through 2.2mm incision
|
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.
Eligibility| Ages Eligible for Study: | 50 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria: Uncomplicated age related cataracts, NO grade II III, IV (LOCS III classification)
-
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
Contacts and Locations| Contact: Abhay R Vasavada, MS,FRCS | 91-79-27490909 | icirc@abhayvasavada.com |
| Contact: Vaishali A Vasavada, MS | 91-79-27492303 | icirc@abhayvasavada.com |
| India | |
| Iladevi Cataract & IOL Research Centre | Recruiting |
| Ahmedabad, Gujarat, India, 380009 | |
| Contact: Abhay r Vasavada, MS,FRCS icirc@abhayvasavada.com | |
| Principal Investigator: Abhay R Vasavada, MS, FRCS | |
| Principal Investigator: | Abhay R Vasavada, MS, FRCS | Iladevi Cataract and IOL Research Center |
More Information
Publications:
| Responsible Party: | Dr. Abhay R. Vasavada, Director, Iladevi Cataract & IOL Research Centre, Iladevi Cataract & IOL Research Centre |
| ClinicalTrials.gov Identifier: | NCT01385878 History of Changes |
| Other Study ID Numbers: | ICIRC-1.8 VS 2.2 |
| Study First Received: | June 29, 2011 |
| Last Updated: | June 29, 2011 |
| Health Authority: | India: Institutional Review Board |
Keywords provided by Iladevi Cataract and IOL Research Center:
|
Microcoaxial phacoemulsification, 1.8mm, 2.2mm |
Additional relevant MeSH terms:
|
Cataract Lens Diseases Eye Diseases |
ClinicalTrials.gov processed this record on May 19, 2013