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

Sponsor
Foundation University Islamabad (Other)
Overall Status
Completed
CT.gov ID
NCT05564455
Collaborator
(none)
70
Enrollment
1
Location
2
Arms
13
Actual Duration (Months)
5.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Biometry with Kane formula
  • Other: Biometry with SRK-T formula
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective, interventional studyProspective, interventional study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of SRK-T With Kane Formula for Prediction of Refractive Outcome After Phacoemulsification
Actual Study Start Date :
Jun 17, 2021
Actual Primary Completion Date :
Jul 17, 2022
Actual Study Completion Date :
Jul 17, 2022

Arms and Interventions

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

Other: Biometry with SRK-T formula
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

Other: Biometry with Kane formula
Kane formulae for intraocular lens (IOL) power calculation in cataract patients

Outcome Measures

Primary Outcome Measures

  1. Visual acuity (Snellen/logMAR) and refractive error (automated refraction in diopters) [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

  2. Spherical equivalent in diopters [1 hour to 1 year]

    The spherical equivalent of the patients will be measured 1 month post-operatively to compare between the two groups

  3. Post-operative refractive outcome in diopters [1 hour to 1 year]

    Post-operative refractive outcome will be compared with intended refractive outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fauji Foundation Hospital Rawalpindi Punjab Pakistan

Sponsors and Collaborators

  • Foundation University Islamabad

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Foundation University Islamabad
ClinicalTrials.gov Identifier:
NCT05564455
Other Study ID Numbers:
  • FUI/CTR/2022/10
First Posted:
Oct 3, 2022
Last Update Posted:
Nov 2, 2022
Last Verified:
Oct 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cataract

Study Results

No Results Posted as of Nov 2, 2022