Cataract SurgeryNCT06548308
Comparison of Corneal Incision Versus Toric Intraocular Lens Techniques Used in Cataract Surgery
A study testing Corneal Incision and Toric Intraocular in people with Cataract Surgery, run by Superior University at 1 site in Pakistan.
Trial summary
Eyesight and quality of life improves in patients after refractive cataract surgery because this surgery treats myopia, hyperopia and presbyopia except astigmatism. In order to make a patient spectacle free Ophthalmologists use different methods during cataract surgery to minimize astigmatism. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Cataract Surgery
- What is being tested?
- Corneal Incision and Toric Intraocular
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2020to 30 Sep 2024
- 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both genders were included.
- Patients having astigmatism was included. Patients having cataract was included.
- Eyes having no other ocular pathology was included.
- Patients having no history of corneal scar was included
Who cannot join
- Eyes having any ocular pathology will be excluded.
- Patients with corneal suture will be excluded.
- Those using contact lenses instead of spectacles for vision correction will be excluded.
- Participants with a history of eye surgery within the past year will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Eyesight and quality of life improves in patients after refractive cataract surgery because this surgery treats myopia, hyperopia and presbyopia except astigmatism. In order to make a patient spectacle free Ophthalmologists use different methods during cataract surgery to minimize astigmatism.
Read the detailed description
These methods includes limbal relaxing incisions (LRIs) or the insertion of toric IOLs, which are specifically intended to cancel out pre-existing astigmatism and astigmatic keratometry. This research will be conducted to see which method benefits more for treating preoperative astigmatism in eye.
- Conditions
- Cataract Surgery
- Being tested
- Corneal Incision, Toric Intraocular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal IncisionDiagnostic test
Astigmatism will be assessed by objective and subjective refraction by using the Autorefrectometer and retinoscop.Autorefrectometer uses to acsess the refracive state of eye by which we measure the astigmatim in patients eyes .Then after ctaract surgry in the next followup we will again use autorefrectometer to take readings and these both will be compared on visits among patients undergoing two procedures.
Toric IntraocularOther
Two cataract surgery techniques will be used .1 : Toric IOL lenses designed with a unique shape to help provide clear vision at all distances for individuals with astigmatism compared to give better results specially in astigmatic patients.2: Corneal Inscion is which eye surgeon makes a very small opening on the eye, next to the outer corner. to remove the catract during surgry .
| Study group | Role | What they receive |
|---|---|---|
| Corneal Incision | Experimental | Not described Receives: Diagnostic Test: Corneal Incision |
| Toric Intraocular | Active comparator | Not described Receives: Other: Toric Intraocular |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative visual acuity
The postoperative visual acuity and refractive outcomes between patients undergoing cataract surgery with corneal incision and those with toric IOL implantation.
Measured: 12 Months
effectiveness of astigmatism correction
Investigate the effectiveness of astigmatism correction achieved by both toric iol and corneal inscion technique and determine the degree of residual astigmatism in both groups after followups .
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start1 Oct 2020
- Primary completion1 Apr 2024
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract SurgeryStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548308
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/734
- Status last verified
- Aug 2024
- First submitted
- 7 Aug 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Corneal Incision Versus Toric Intraocular Lens Techniques Used in Cataract Surgery
- ClinicalTrials.gov ID
- NCT06548308
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/734
- Conditions
- Cataract Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 368 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 12 Aug 2024 (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.
Eyesight and quality of life improves in patients after refractive cataract surgery because this surgery treats myopia, hyperopia and presbyopia except astigmatism. In order to make a patient spectacle free Ophthalmologists use different methods during cataract surgery to minimize astigmatism.
Detailed description
These methods includes limbal relaxing incisions (LRIs) or the insertion of toric IOLs, which are specifically intended to cancel out pre-existing astigmatism and astigmatic keratometry. This research will be conducted to see which method benefits more for treating preoperative astigmatism in eye.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corneal Incision | Experimental | Diagnostic Test: Corneal Incision |
| Toric Intraocular | Active comparator | Other: Toric Intraocular |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Both genders were included.
- Patients having astigmatism was included. Patients having cataract was included.
- Eyes having no other ocular pathology was included.
- Patients having no history of corneal scar was included
Key exclusion criteria (4 listed)
- Eyes having any ocular pathology will be excluded.
- Patients with corneal suture will be excluded.
- Those using contact lenses instead of spectacles for vision correction will be excluded.
- Participants with a history of eye surgery within the past year will be excluded.
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 |
|---|---|---|
| Corneal IncisionAstigmatism will be assessed by objective and subjective refraction by using the Autorefrectometer and retinoscop.Autorefrectometer uses to acsess the refracive state of eye by which we measure the astigmatim in patients eyes .Then after ctaract surgry in the next followup we will again use autorefrectometer to take readings and these both will be compared on visits among patients undergoing two procedures. | Diagnostic test | Corneal Incision |
| Toric IntraocularTwo cataract surgery techniques will be used .1 : Toric IOL lenses designed with a unique shape to help provide clear vision at all distances for individuals with astigmatism compared to give better results specially in astigmatic patients.2: Corneal Inscion is which eye surgeon makes a very small opening on the eye, next to the outer corner. to remove the catract during surgry . | Other | Toric Intraocular |
Primary outcome
postoperative visual acuity
Time frame: 12 Months
The postoperative visual acuity and refractive outcomes between patients undergoing cataract surgery with corneal incision and those with toric IOL implantation.
effectiveness of astigmatism correction
Time frame: 12 months
Investigate the effectiveness of astigmatism correction achieved by both toric iol and corneal inscion technique and determine the degree of residual astigmatism in both groups after followups .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Individual participant dataSharing planned: No
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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 Corneal Incision and Toric Intraocular in people with Cataract Surgery, run by Superior University 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 4 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: status not confirmed, as of the sponsor's last update on 12 Aug 2024. 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?
Results are not available in the source record.
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?
postoperative visual acuity (time frame: 12 Months). The study lists 2 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 12 Aug 2024.