Cataract; Surgery; Phacoemulsification; Biometry; Intraocular Lens PowerNCT05564455
Comparison of SRK-T With Kane Formula for Prediction of Refractive Outcome After Phacoemulsification
A study testing Biometry with Kane formula and Biometry with SRK-T formula in people with Cataract; Surgery; Phacoemulsification; Biometry; Intraocular Lens Power, run by Foundation University Islamabad at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract; Surgery; Phacoemulsification; Biometry; Intraocular Lens Power
- What is being tested?
- Biometry with Kane formula and Biometry with SRK-T formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Jun 2021to 17 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Retinal diseases
- Maculopathy
- Uveitis
- Complications during phacoemulsification
- Combined procedures
- Previous ocular surgery
- Trauma
- Secondary cataract
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Biometry with Kane formula, Biometry with SRK-T formula
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biometry with Kane formulaOther
Kane formulae for intraocular lens (IOL) power calculation in cataract patients
Biometry with SRK-T formulaOther
Sanders Retzlaff Kraff theoretical (SRK T) formulae for intraocular lens (IOL) power calculation in cataract patients
| Study group | Role | What they receive |
|---|---|---|
| SRK-T Formula for Prediction of refraction | Active comparator | 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 Receives: Other: Biometry with SRK-T formula |
| Kane Formula for Prediction of refraction | Active comparator | 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 Receives: Other: Biometry with Kane formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month post-operatively
Spherical equivalent in diopters
The spherical equivalent of the patients will be measured 1 month post-operatively to compare between the two groups
Measured: 1 hour to 1 year
Post-operative refractive outcome in diopters
Post-operative refractive outcome will be compared with intended refractive outcome
Measured: 1 hour to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start17 Jun 2021
- Primary completion17 Jul 2022
- Study completion17 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract; Surgery; Phacoemulsification; Biometry; Intraocular Lens PowerStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, interventional study
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05564455
- Sponsor's protocol ID
- FUI/CTR/2022/10
- Status last verified
- Oct 2022
- First submitted
- 29 Sep 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of SRK-T With Kane Formula for Prediction of Refractive Outcome After Phacoemulsification
- ClinicalTrials.gov ID
- NCT05564455
- Acronym / sponsor ID
- FUI/CTR/2022/10
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 17 Jul 2022 (actual)
- Study completion
- 17 Jul 2022 (actual)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, interventional study
| Arm | Type | Receives |
|---|---|---|
| SRK-T Formula for Prediction of refraction | Active comparator | Other: Biometry with SRK-T formulaTo 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 Formula for Prediction of refraction | Active comparator | Other: Biometry with Kane formulaTo compare post-operative refractive outcome with Sanders Retzlaff Kraff theoretical (SRK T) and Kane formulae for intraocular lens (IOL) power calculation in cataract patients |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Retinal diseases
- Maculopathy
- Uveitis
- Complications during phacoemulsification
- Combined procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biometry with Kane formulaKane formulae for intraocular lens (IOL) power calculation in cataract patients | Other | Kane Formula for Prediction of refraction |
| Biometry with SRK-T formulaSanders Retzlaff Kraff theoretical (SRK T) formulae for intraocular lens (IOL) power calculation in cataract patients | Other | SRK-T Formula for Prediction of refraction |
Primary outcome
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
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
Post-operative refractive outcome in diopters
Time frame: 1 hour to 1 year
Post-operative refractive outcome will be compared with intended refractive outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
Related trials for Cataract; Surgery; Phacoemulsification; Biometry; Intraocular Lens Power
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Effect of Dry Eye Disease on Accuracy of Intraocular Lens Power Calculation Before Phacoemulsification
Dry Eye Disease (DED), Cataract (Post-operative Cataract Surgery Follow-up)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biometry with Kane formula and Biometry with SRK-T formula in people with Cataract; Surgery; Phacoemulsification; Biometry; Intraocular Lens Power, run by Foundation University Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (Snellen/logMAR) and refractive error (automated refraction in diopters) (time frame: 1 month post-operatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.