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Comparison of SRK-T With Kane Formula for Prediction of Refractive Outcome After Phacoemulsification

Primary Purpose

Cataract; Surgery; Phacoemulsification; Biometry; Intraocular Lens Power

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Biometry with Kane formula
Biometry with SRK-T formula
Sponsored by
Foundation University Islamabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract; Surgery; Phacoemulsification; Biometry; Intraocular Lens Power

Eligibility Criteria

40 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Fauji Foundation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

SRK-T Formula for Prediction of refraction

Kane Formula for Prediction of refraction

Arm Description

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

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

Outcomes

Primary Outcome Measures

Visual acuity (Snellen/logMAR) and refractive error (automated refraction in diopters)
The visual acuity and refractive error of the patients will be measured 1 month post-operatively to compare between the two groups
Spherical equivalent in diopters
The spherical equivalent of the patients will be measured 1 month post-operatively to compare between the two groups
Post-operative refractive outcome in diopters
Post-operative refractive outcome will be compared with intended refractive outcome

Secondary Outcome Measures

Full Information

First Posted
September 29, 2022
Last Updated
October 31, 2022
Sponsor
Foundation University Islamabad
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1. Study Identification

Unique Protocol Identification Number
NCT05564455
Brief Title
Comparison of SRK-T With Kane Formula for Prediction of Refractive Outcome After Phacoemulsification
Official Title
Comparison of SRK-T With Kane Formula for Prediction of Refractive Outcome After Phacoemulsification
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 17, 2021 (Actual)
Primary Completion Date
July 17, 2022 (Actual)
Study Completion Date
July 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation University Islamabad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Cataract is a leading cause of blindness in the world. Cataract surgery is one of the most commonly performed ocular procedures. We aim to compare the newer generation biometry formula; the Kane formula with the commonly used SRK-T formula for intraocular power calculation in uneventful phacoemulsification surgery to assess the post-operative refractive outcomes at one month post-surgery.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract; Surgery; Phacoemulsification; Biometry; Intraocular Lens Power

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, interventional study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SRK-T Formula for Prediction of refraction
Arm Type
Active Comparator
Arm Description
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
Arm Title
Kane Formula for Prediction of refraction
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Biometry with Kane formula
Intervention Description
Kane formulae for intraocular lens (IOL) power calculation in cataract patients
Intervention Type
Other
Intervention Name(s)
Biometry with SRK-T formula
Intervention Description
Sanders Retzlaff Kraff theoretical (SRK T) formulae for intraocular lens (IOL) power calculation in cataract patients
Primary Outcome Measure Information:
Title
Visual acuity (Snellen/logMAR) and refractive error (automated refraction in diopters)
Description
The visual acuity and refractive error of the patients will be measured 1 month post-operatively to compare between the two groups
Time Frame
1 month post-operatively
Title
Spherical equivalent in diopters
Description
The spherical equivalent of the patients will be measured 1 month post-operatively to compare between the two groups
Time Frame
1 hour to 1 year
Title
Post-operative refractive outcome in diopters
Description
Post-operative refractive outcome will be compared with intended refractive outcome
Time Frame
1 hour to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Fauji Foundation Hospital
City
Rawalpindi
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

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Comparison of SRK-T With Kane Formula for Prediction of Refractive Outcome After Phacoemulsification

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