AstigmatismPhase 4NCT04418986
Incisional Correction of Corneal Astigmatism During Phacoemulsification
A Phase 4 study testing opposite clear corneal incisions (OCCI) in people with Astigmatism, run by Al-Rasheed University College at 1 site in Iraq.
Trial summary
Today, cataract surgery is regarded as refractive surgery, mainly aiming emmetropia, and this makes eliminating corneal astigmatism is critical. Corneal astigmatism of more than 1 diopter has been reported in up to 45% of the cataract surgery candidates. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Astigmatism
- What is being tested?
- opposite clear corneal incisions (OCCI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jul 2019to 30 Sep 2019
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clear cornea
- No history of previous ocular surgery
- Central corneal thickness (CCT) <640
Who cannot join
- Irregular corneal astigmatism or lenticular astigmatism
- Corneal opacities or pathology like Fuch's endothelial dystrophy
- Previous ocular surgeries like glaucoma surgery or PKP or pterygium excision
- Posterior segment diseases and pathology
- Complicated phacoemulsification
Trial locations and contacts
1 site in 1 country.
Iraq1 site
Ghazi al-Hariri Surgical Specialties Hospital
Baghdad, Bab-Almuadham, 12221
About this study
Today, cataract surgery is regarded as refractive surgery, mainly aiming emmetropia, and this makes eliminating corneal astigmatism is critical. Corneal astigmatism of more than 1 diopter has been reported in up to 45% of the cataract surgery candidates.
It is possible to reduce pre-existing corneal astigmatism by creating a clear corneal incision at the steep meridian of the cornea, however; creating a small incision can correct the only astigmatism up to 1 Diopter, and sometimes this method may not be easy to perform due to the location of steep meridian like the difficulty while creating a superonasal or inferonasal incision at the left eye. This approach is usually sufficient for correcting astigmatism less than 1 D in most eyes. An opposite side clear corneal incision (OCCI) could enhance the flattening effect on the cornea.
- Conditions
- Astigmatism
- Being tested
- opposite clear corneal incisions (OCCI)
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
opposite clear corneal incisions (OCCI)Procedure or surgery
Coaxial small incision cataract surgery was performed for all cases using a 2.8 mm keratome placed at steep meridian and 1-mm paracentesis was made 90 degrees apart with a 20-gauge microvitrectomy blade. Surgery was performed with a 30-degree, 0.9-caliper phacoemulsification tip (microtip) with a divide and conquer technique.
In the OCCI group, a single penetrating incision was created with 2.8 mm keratome in the clear cornea, 1.5 mm anterior to limbal blood vessels, centered over the steep meridian and opposite the phacoemulsification incision.
| Study group | Role | What they receive |
|---|---|---|
| Control (CCI Group) | Sham comparator | The Participants will undergo phacoemulsification with on-axis incision Receives: Procedure: opposite clear corneal incisions (OCCI) |
| Study (OCCI Group) | Active comparator | The Participants will undergo phacoemulsification with opposite clear corneal incisions Receives: Procedure: opposite clear corneal incisions (OCCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean astigmatic correction
Astigmatic correction change after the correction surgery
Measured: After 1 month of surgery
Mean surgically induced astigmatism
Mean surgically induced astigmatism, measured by a vector-corrected method
Measured: After 1 month of surgery
Secondary outcomes (1)
Change in visual acuity
Uncorrected visual acuity and best corrected visual acuity after the surgery
Measured: After 1 month of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start1 Jul 2019
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AstigmatismStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, parallel two-arm interventional study, the patients were divided into a 1:1 ratio, the study included eyes with visually significant cataract and preoperative corneal regular astigmatism between 0.75 and 2 Diopters undergoing phacoemulsification surgery. They were divided into two groups: controls underwent phacoemulsification with on-axis incision (CCI Group), and patients underwent phacoemulsification with opposite clear corneal incisions (OCCI Group).
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Rasheed University College
- Sponsor type
- University, hospital or other
- Collaborators
- Baghdad Medical City
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418986
- Sponsor's protocol ID
- AR200105
- Status last verified
- Jun 2020
- First submitted
- 3 Jun 2020
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incisional Correction of Corneal Astigmatism During Phacoemulsification
- ClinicalTrials.gov ID
- NCT04418986
- Acronym / sponsor ID
- AR200105
- Conditions
- Astigmatism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Al-Rasheed University CollegeUniversity, hospital or other
- Collaborators
- Baghdad Medical City
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 5 Jun 2020 (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.
Today, cataract surgery is regarded as refractive surgery, mainly aiming emmetropia, and this makes eliminating corneal astigmatism is critical. Corneal astigmatism of more than 1 diopter has been reported in up to 45% of the cataract surgery candidates.
It is possible to reduce pre-existing corneal astigmatism by creating a clear corneal incision at the steep meridian of the cornea, however; creating a small incision can correct the only astigmatism up to 1 Diopter, and sometimes this method may not be easy to perform due to the location of steep meridian like the difficulty while creating a superonasal or inferonasal incision at the left eye. This approach is usually sufficient for correcting astigmatism less than 1 D in most eyes. An opposite side clear corneal incision (OCCI) could enhance the flattening effect on the cornea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized, parallel two-arm interventional study, the patients were divided into a 1:1 ratio, the study included eyes with visually significant cataract and preoperative corneal regular astigmatism between 0.75 and 2 Diopters undergoing phacoemulsification surgery. They were divided into two groups: controls underwent phacoemulsification with on-axis incision (CCI Group), and patients underwent phacoemulsification with opposite clear corneal incisions (OCCI Group).
| Arm | Type | Receives |
|---|---|---|
| Control (CCI Group) | Sham comparator | Procedure: opposite clear corneal incisions (OCCI)The Participants will undergo phacoemulsification with on-axis incision |
| Study (OCCI Group) | Active comparator | Procedure: opposite clear corneal incisions (OCCI)The Participants will undergo phacoemulsification with opposite clear corneal incisions |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Clear cornea
- No history of previous ocular surgery
- Central corneal thickness (CCT) <640
Key exclusion criteria (5 listed)
- Irregular corneal astigmatism or lenticular astigmatism
- Corneal opacities or pathology like Fuch's endothelial dystrophy
- Previous ocular surgeries like glaucoma surgery or PKP or pterygium excision
- Posterior segment diseases and pathology
- Complicated phacoemulsification
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 |
|---|---|---|
| opposite clear corneal incisions (OCCI)Coaxial small incision cataract surgery was performed for all cases using a 2.8 mm keratome placed at steep meridian and 1-mm paracentesis was made 90 degrees apart with a 20-gauge microvitrectomy blade. Surgery was performed with a 30-degree, 0.9-caliper phacoemulsification tip (microtip) with a divide and conquer technique. In the OCCI group, a single penetrating incision was created with 2.8 mm keratome in the clear cornea, 1.5 mm anterior to limbal blood vessels, centered over the steep meridian and opposite the phacoemulsification incision. | Procedure or surgery | Control (CCI Group), Study (OCCI Group) |
Primary outcome
Mean astigmatic correction
Time frame: After 1 month of surgery
Astigmatic correction change after the correction surgery
Mean surgically induced astigmatism
Time frame: After 1 month of surgery
Mean surgically induced astigmatism, measured by a vector-corrected method
1 secondary outcome
Change in visual acuity
Time frame: After 1 month of surgery
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 5 Jun 2020.
- Individual participant dataSharing planned: Yes
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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 Phase 4 study testing opposite clear corneal incisions (OCCI) in people with Astigmatism, run by Al-Rasheed University College at 1 site in Iraq.
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 3 inclusion and 5 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 5 Jun 2020. 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 Iraq. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mean astigmatic correction (time frame: After 1 month of surgery). 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 5 Jun 2020.