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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01385878
Enrollment
110
Registered
2011-06-30
Start date
2011-01-31
Completion date
2011-12-31
Last updated
2011-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

Microcoaxial phacoemulsification, 1.8mm, 2.2mm

Brief 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 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.

Interventions

Phacoemulsification through small clear corneal incision

Sponsors

Iladevi Cataract and IOL Research Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Ingress of Trypan blue from the Ocular Surface into the Anterior ChamberImmediately at the end of surgeryAt 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

Secondary

MeasureTime frame
Surgically Induced AstigmatismAt baseline and 3 months postoperatively
Corneal Endothelial Cell LossBaseline and 3 months postoperatively
Change in Central Corneal ThicknessBaseline and 1 week
Anterior Chamber InflammationBaseline and 1 week

Countries

India

Contacts

Primary ContactAbhay R Vasavada, MS,FRCS
icirc@abhayvasavada.com91-79-27490909
Backup ContactVaishali A Vasavada, MS
icirc@abhayvasavada.com91-79-27492303

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026