- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05564455
Comparison of SRK-T With Kane Formula for Prediction of Refractive Outcome After Phacoemulsification
Study Overview
Status
Intervention / Treatment
Detailed Description
Purpose: To compare post-operative refractive outcome with Sanders Retzlaff Kraff theoretical (SRK T) and Kane formulae for intraocular lens (IOL) power calculation in cataract patients Study Design: Prospective, interventional study Place and Duration of Study: Department of Ophthalmology, Fauji Foundation Hospital, Rawalpindi Material and Methods: A total of a 70 eyes, 35 in each group will be included in our study. The patients will be randomly divided into two groups. In cases of bilateral cataract, one eye will be included in each group for better control. IOL power calculation in Group A will be done with the SRK-T formula and in group 2 with the Kane Formula. Autokeratometry and A-scan ultrasound will be done for biometry. Inclusion criteria will be uncomplicated cataract in both genders. Exclusion criteria will be ocular trauma, uveitis, previous intraocular surgery, or any retinopathy. All patients will undergo phacoemulsification with foldable lens implantation by two experienced surgeons. Post-operative refractive outcome will be evaluated at one month after surgery. The two groups will be compared.
Results: The results will be calculated by SPSS. Conclusion: A conclusion will be drawn on the basis of our results.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Rawalpindi, Punjab, Pakistan
- Fauji Foundation Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Senile cataract (nuclear, cortical, posterior subcapsular, mature, hypermature cataract)
- Absence of other ocular pathology causing diminished visual acuity
- patients above 40 years of age
- Astigmatism > 2.5 diopters
Exclusion Criteria:
- Retinal diseases
- Maculopathy
- Uveitis
- Complications during phacoemulsification
- Combined procedures
- Previous ocular surgery
- Trauma
- Secondary cataract
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: SRK-T Formula for Prediction of refraction
To compare post-operative refractive outcome with Sanders Retzlaff Kraff theoretical (SRK T) and Kane formulae for intraocular lens (IOL) power calculation in cataract patients
|
Sanders Retzlaff Kraff theoretical (SRK T) formulae for intraocular lens (IOL) power calculation in cataract patients
|
|
Active Comparator: Kane Formula for Prediction of refraction
To compare post-operative refractive outcome with Sanders Retzlaff Kraff theoretical (SRK T) and Kane formulae for intraocular lens (IOL) power calculation in cataract patients
|
Kane formulae for intraocular lens (IOL) power calculation in cataract patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual acuity (Snellen/logMAR) and refractive error (automated refraction in diopters)
Time Frame: 1 month post-operatively
|
The visual acuity and refractive error of the patients will be measured 1 month post-operatively to compare between the two groups
|
1 month post-operatively
|
|
Spherical equivalent in diopters
Time Frame: 1 hour to 1 year
|
The spherical equivalent of the patients will be measured 1 month post-operatively to compare between the two groups
|
1 hour to 1 year
|
|
Post-operative refractive outcome in diopters
Time Frame: 1 hour to 1 year
|
Post-operative refractive outcome will be compared with intended refractive outcome
|
1 hour to 1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUI/CTR/2022/10
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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