CataractNCT01385878
Outcomes Following Phacoemulsification With 1.8 & 2.2mm Incision: Randomized Clinical Trial
A study testing Microcoaxial Phacoemulsification in people with Cataract, run by Iladevi Cataract and IOL Research Center at 1 site in India.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Cataract
- 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
- 110 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2011to Dec 2011
- Phase
- Interventional
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Iladevi Cataract & IOL Research Centre
Ahmedabad, Gujarat, 380009
Abhay r Vasavada, MS,FRCS, icirc@abhayvasavada.com
Abhay R Vasavada, MS, FRCS
About this study
Official title: 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.
Read the 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.
- Conditions
- Cataract
- Being tested
- Microcoaxial Phacoemulsification
- Keywords
- Microcoaxial phacoemulsification, 1.8mm, 2.2mm
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microcoaxial PhacoemulsificationProcedure or surgery
Phacoemulsification through small clear corneal incision
Microcoaxial PhacoemulsificationProcedure or surgery
Phacoemulsification through clear corneal incision
Microcoaxial PhacoemulsificationProcedure or surgery
Microcoaxial Phacoemulsification through 1.8mm incision
Microcoaxial PhacoemulsificationProcedure or surgery
Microcoaxial phacoemulsification through 2.2mm incision
| Study group | Role | What they receive |
|---|---|---|
| Phacoemulsification with 1.8mm incision | Active comparator | Microcoaxial phacoemulsification was performed using a 1.8mm clear corneal incision Receives: Procedure: Microcoaxial Phacoemulsification |
| Phacoemulsification with 2.2mm incisi | Active comparator | Microcoaxial phacoemulsificaiton will be performed through 2.2mm incision Receives: Procedure: Microcoaxial Phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ingress of Trypan blue from the Ocular Surface into the Anterior Chamber
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
Measured: Immediately at the end of surgery
Secondary outcomes (5)
Surgically Induced Astigmatism
Measured: At baseline and 3 months postoperatively
Corneal Endothelial Cell Loss
Measured: Baseline and 3 months postoperatively
Change in Central Corneal Thickness
Measured: Baseline and 1 week
Anterior Chamber Inflammation
Measured: Baseline and 1 week
Anterior Chamber Inflammation
Measured: Baseline and 1 month
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 startJan 2011
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iladevi Cataract and IOL Research Center
- Sponsor type
- University, hospital or other
- Investigators
- Abhay R Vasavada, MS, FRCS, Principal investigator, Iladevi Cataract and IOL Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385878
- Sponsor's protocol ID
- ICIRC-1.8 VS 2.2
- Status last verified
- Jun 2011
- First submitted
- 29 Jun 2011
- Last updated
- 30 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee KM, Kwon HG, Joo CK. Microcoaxial cataract surgery outcomes: comparison of 1.8 mm system and 2.2 mm system. J Cataract Refract Surg. 2009 May;35(5):874-80. doi: 10.1016/j.jcrs.2008.12.031.
PubMed 19393887
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Performance & Postoperative Outcomes Following Phacoemulsification With 1.8 & 2.2mm Incision: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01385878
- Acronym / sponsor ID
- ICIRC-1.8 VS 2.2
- Conditions
- Cataract
- Keywords
- Microcoaxial phacoemulsification, 1.8mm, 2.2mm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Iladevi Cataract and IOL Research CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phacoemulsification with 1.8mm incision | Active comparator | Procedure: Microcoaxial PhacoemulsificationMicrocoaxial phacoemulsification was performed using a 1.8mm clear corneal incision |
| Phacoemulsification with 2.2mm incisi | Active comparator | Procedure: Microcoaxial PhacoemulsificationMicrocoaxial phacoemulsificaiton will be performed through 2.2mm incision |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 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
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 PhacoemulsificationPhacoemulsification through small clear corneal incision | Procedure or surgery | Phacoemulsification with 1.8mm incision, Phacoemulsification with 2.2mm incisi |
| Microcoaxial PhacoemulsificationPhacoemulsification through clear corneal incision | Procedure or surgery | Phacoemulsification with 1.8mm incision, Phacoemulsification with 2.2mm incisi |
| Microcoaxial PhacoemulsificationMicrocoaxial Phacoemulsification through 1.8mm incision | Procedure or surgery | Phacoemulsification with 1.8mm incision, Phacoemulsification with 2.2mm incisi |
| Microcoaxial PhacoemulsificationMicrocoaxial phacoemulsification through 2.2mm incision | Procedure or surgery | Phacoemulsification with 2.2mm incisi |
Primary outcome
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
5 secondary outcomes
Surgically Induced Astigmatism
Time frame: At baseline and 3 months postoperatively
Corneal Endothelial Cell Loss
Time frame: Baseline and 3 months postoperatively
Change in Central Corneal Thickness
Time frame: Baseline and 1 week
Anterior Chamber Inflammation
Time frame: Baseline and 1 week
Anterior Chamber Inflammation
Time frame: Baseline and 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2011.
- Background: PubMed 19393887Lee KM, Kwon HG, Joo CK. Microcoaxial cataract surgery outcomes: comparison of 1.8 mm system and 2.2 mm system. J Cataract Refract Surg. 2009 May;35(5):874-80. doi: 10.1016/j.jcrs.2008.12.031.
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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.
Abhay R Vasavada, MS, FRCS principal investigator
Iladevi Cataract and IOL Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microcoaxial Phacoemulsification in people with Cataract, 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 0 inclusion and 1 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 30 Jun 2011. 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.
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?
Contact Abhay R Vasavada, MS,FRCS (91-79-27490909, icirc@abhayvasavada.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ingress of Trypan blue from the Ocular Surface into the Anterior Chamber (time frame: Immediately at the end of surgery). 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 NCT01385878, which also lists 1 linked publication.
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 30 Jun 2011.