Outcome Following Phacoemulsification Versus Small Incision Cataract Surgery (SICS)
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ClinicalTrials.gov Identifier: NCT00821223 |
Recruitment Status :
Completed
First Posted : January 13, 2009
Last Update Posted : May 19, 2010
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Hypothesis :
Phacoemulsification is superior to SICS with regards to:
- Immediate unaided high and low contrast visual performance
- Its impact on quality of life.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Visual Outcomes Quality of Life | Procedure: phacoemulsification and SICS Procedure: manual small incision surgery Procedure: phacoemulsification | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 420 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Comparison of Phacoemulsification Versus Manual Small Incision Cataract Surgery (SICS) : A Randomized Control Trial |
Study Start Date : | February 2009 |
Actual Primary Completion Date : | May 2010 |
Actual Study Completion Date : | May 2010 |
Arm | Intervention/treatment |
---|---|
Active Comparator: manual small incision cataract surgery
surgical intervention by small incision cataract surgery
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Procedure: manual small incision surgery
Other Name: exrtracapsular cataract surgery |
phacoemulsification
surgical intervention by phacoemulsification
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Procedure: phacoemulsification and SICS
SICS with rigid IOL implantation Phaco with foldable IOL implantation
Other Names:
Procedure: phacoemulsification cataract surgery
Other Name: extracapsualr cataract surgery |
- immediate unaided and aided visual acuity [ Time Frame: immediate and mid term (12 months) ]
- 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 ]

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Ages Eligible for Study: | 50 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821223
India | |
S. K. Red Cross Eye Hospital, | |
Dholka, Gujarat, India |
Principal Investigator: | Alpesh R Shah, Dr | Iladevi Cataract and IOL Research Center |
Responsible Party: | Dr. Alpesh Shah, Iladevi Cataract and IOL Research Center, Ahmedabad, India |
ClinicalTrials.gov Identifier: | NCT00821223 |
Other Study ID Numbers: |
009 |
First Posted: | January 13, 2009 Key Record Dates |
Last Update Posted: | May 19, 2010 |
Last Verified: | May 2010 |
phacoemulsification manual small incision cataract surgery visual acuity contrast sensitivity quality of vision |
Cataract Surgical Wound Lens Diseases Eye Diseases Wounds and Injuries |