Visual OutcomesNCT00821223
Outcome Following Phacoemulsification Versus Small Incision Cataract Surgery (SICS)
A study testing phacoemulsification and SICS, manual small incision surgery and phacoemulsification in people with Visual Outcomes and Quality of Life, run by Iladevi Cataract and IOL Research Center at 1 site in India.
Trial summary
Hypothesis : Phacoemulsification is superior to SICS with regards to: Immediate unaided high and low contrast visual performance Its impact on quality of life. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Visual Outcomes, Quality of Life
- What is being tested?
- phacoemulsification and SICS, manual small incision surgery and phacoemulsification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2009to May 2010
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prospective subjects should be diagnosed with senile cataract. Subject must require extraction of cataract in one eye followed by implantation of an AcrySof (SN60WF) or PMMA (MZ60BD) posterior chamber intraocular lens.
- Pupil dilation equal or greater to 7 mm after mydriasis.
- Patients undergoing cataract surgery for the first eye.
- Visual prognosis equal or greater to 6/12.
Who cannot join
- Patients with history of ocular pathology, glaucoma, uveitis, high myopia, PEX, or corneal pathology.
- Patients with traumatic, subluxated and posterior polar cataract.
- Patients who had previously ocular surgery in the past 6 months prior to the screening visit.
- Patients with diabetic retinopathy.
- Patients who are not suitable for follow-up visits.
- Patients with Fuchs' Dystrophy, Macular Degeneration, Ocular Surface Disease that will interfere with normal recovery.
- Any patients with significant intra-operative complications will be removed from the overall analysis of the results. All patient data should still be recorded, even if from the "excluded" patient group.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Phacoemulsification Versus Manual Small Incision Cataract Surgery (SICS) : A Randomized Control Trial
Hypothesis :
Phacoemulsification is superior to SICS with regards to:
- Immediate unaided high and low contrast visual performance
- Its impact on quality of life.
Read the detailed description
Phacoemulsification procedure
- Infiniti Vision System with Software 2.03 or higher, OZil handpiece (HP)
- Anaesthesia: topical
- Incision: temporal clear corneal 2.2 mm single plane
- CCC and hydrodissection, sculpting and division using step by step chop in situ and lateral separation, I/A.
- Single-piece AcrySof IOL (SN60WF) in the bag
SICS procedure
- Anaesthesia: peribulbar
- Incision: superior scleral tunnel 6.5 to 7 mm
- CCC and hydrodissection
- Nuclear expression: blumenthal technique using anterior chamber maintainer, manual cortical clean-up
- Single-piece PMMA (MZ60BD) in the bag
- Conditions
- Visual Outcomes, Quality of Life
- Being tested
- phacoemulsification and SICS, manual small incision surgery, phacoemulsification
- Keywords
- phacoemulsification, manual small incision cataract surgery, visual acuity, contrast sensitivity, quality of vision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phacoemulsification and SICSProcedure or surgery
Also called ECCE, Manual SICS
SICS with rigid IOL implantation Phaco with foldable IOL implantation
manual small incision surgeryProcedure or surgery
Also called exrtracapsular cataract surgery
phacoemulsificationProcedure or surgery
Also called extracapsualr cataract surgery
cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| manual small incision cataract surgery | Active comparator | surgical intervention by small incision cataract surgery Receives: Procedure: manual small incision surgery |
| phacoemulsification | Other | surgical intervention by phacoemulsification Receives: Procedure: phacoemulsification and SICS; Procedure: phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
immediate unaided and aided visual acuity
Measured: immediate and mid term (12 months)
Secondary outcomes (3)
Assessment of unaided and aided low contrast sensitivity
Measured: 3 and 12 months
Intra-operative complications immediate post-operative day corneal edema anterior chamber inflammation
Measured: day 1, 1 week
To assess improvement in quality of life
Measured: 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Visual OutcomesStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iladevi Cataract and IOL Research Center
- Sponsor type
- University, hospital or other
- Investigators
- Alpesh R Shah, Dr, Principal investigator, Iladevi Cataract and IOL Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821223
- Sponsor's protocol ID
- 009
- Status last verified
- May 2010
- First submitted
- 9 Jan 2009
- Last updated
- 19 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gogate P, Deshpande M, Nirmalan PK. Why do phacoemulsification? Manual small-incision cataract surgery is almost as effective, but less expensive. Ophthalmology. 2007 May;114(5):965-8. doi: 10.1016/j.ophtha.2006.08.057. Epub 2007 Feb 12.
PubMed 17296230Ruit S, Tabin G, Chang D, Bajracharya L, Kline DC, Richheimer W, Shrestha M, Paudyal G. A prospective randomized clinical trial of phacoemulsification vs manual sutureless small-incision extracapsular cataract surgery in Nepal. Am J Ophthalmol. 2007 Jan;143(1):32-38. doi: 10.1016/j.ajo.2006.07.023. Epub 2006 Sep 5.
PubMed 17188040
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Phacoemulsification Versus Manual Small Incision Cataract Surgery (SICS) : A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT00821223
- Acronym / sponsor ID
- 009
- Conditions
- Visual Outcomes, Quality of Life
- Keywords
- phacoemulsification, manual small incision cataract surgery, visual acuity, contrast sensitivity, quality of vision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Iladevi Cataract and IOL Research CenterUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 13 Jan 2009 (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.
Hypothesis :
Phacoemulsification is superior to SICS with regards to:
- Immediate unaided high and low contrast visual performance
- Its impact on quality of life.
Detailed description
Phacoemulsification procedure
- Infiniti Vision System with Software 2.03 or higher, OZil handpiece (HP)
- Anaesthesia: topical
- Incision: temporal clear corneal 2.2 mm single plane
- CCC and hydrodissection, sculpting and division using step by step chop in situ and lateral separation, I/A.
- Single-piece AcrySof IOL (SN60WF) in the bag
SICS procedure
- Anaesthesia: peribulbar
- Incision: superior scleral tunnel 6.5 to 7 mm
- CCC and hydrodissection
- Nuclear expression: blumenthal technique using anterior chamber maintainer, manual cortical clean-up
- Single-piece PMMA (MZ60BD) in the bag
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| manual small incision cataract surgery | Active comparator | Procedure: manual small incision surgerysurgical intervention by small incision cataract surgery |
| phacoemulsification | Other | Procedure: phacoemulsification and SICS, Procedure: phacoemulsificationsurgical intervention by phacoemulsification |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Prospective subjects should be diagnosed with senile cataract. Subject must require extraction of cataract in one eye followed by implantation of an AcrySof (SN60WF) or PMMA (MZ60BD) posterior chamber intraocular lens.
- Pupil dilation equal or greater to 7 mm after mydriasis.
- Patients undergoing cataract surgery for the first eye.
- Visual prognosis equal or greater to 6/12.
Key exclusion criteria (7 listed)
- Patients with history of ocular pathology, glaucoma, uveitis, high myopia, PEX, or corneal pathology.
- Patients with traumatic, subluxated and posterior polar cataract.
- Patients who had previously ocular surgery in the past 6 months prior to the screening visit.
- Patients with diabetic retinopathy.
- Patients who are not suitable for follow-up visits.
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 |
|---|---|---|
| phacoemulsification and SICSAlso: ECCE, Manual SICSSICS with rigid IOL implantation Phaco with foldable IOL implantation | Procedure or surgery | phacoemulsification |
| manual small incision surgeryAlso: exrtracapsular cataract surgery | Procedure or surgery | manual small incision cataract surgery |
| phacoemulsificationAlso: extracapsualr cataract surgerycataract surgery | Procedure or surgery | phacoemulsification |
Primary outcome
immediate unaided and aided visual acuity
Time frame: immediate and mid term (12 months)
3 secondary outcomes
Assessment of unaided and aided low contrast sensitivity
Time frame: 3 and 12 months
Intra-operative complications immediate post-operative day corneal edema anterior chamber inflammation
Time frame: day 1, 1 week
To assess improvement in quality of life
Time frame: 3 and 12 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 19 May 2010.
- Results publication: PubMed 17296230Gogate P, Deshpande M, Nirmalan PK. Why do phacoemulsification? Manual small-incision cataract surgery is almost as effective, but less expensive. Ophthalmology. 2007 May;114(5):965-8. doi: 10.1016/j.ophtha.2006.08.057. Epub 2007 Feb 12.
- Results publication: PubMed 17188040Ruit S, Tabin G, Chang D, Bajracharya L, Kline DC, Richheimer W, Shrestha M, Paudyal G. A prospective randomized clinical trial of phacoemulsification vs manual sutureless small-incision extracapsular cataract surgery in Nepal. Am J Ophthalmol. 2007 Jan;143(1):32-38. doi: 10.1016/j.ajo.2006.07.023. Epub 2006 Sep 5.
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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.
Alpesh R Shah, Dr 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 phacoemulsification and SICS, manual small incision surgery and phacoemulsification in people with Visual Outcomes and Quality of Life, 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 19 May 2010. 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?
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?
immediate unaided and aided visual acuity (time frame: immediate and mid term (12 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 NCT00821223, which also lists 2 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 19 May 2010.