Surrgical Induced AstigmatismNCT00521833
Surgically Induced Astigmatism of Temporal Versus Nasal Clear Corneal Phacoemulsification
A study testing phacoemulsification and intraocular lens implantation in people with Surrgical Induced Astigmatism, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
To compare the short-term astigmatic outcomes of phacoemulsification cataract surgery and intraocular lens implantation using temporal versus nasal clear corneal incisions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surrgical Induced Astigmatism
- What is being tested?
- phacoemulsification and intraocular lens implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIran
- Study dates
- Jun 2005to Aug 2006
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All the patients with senile cataract
Who cannot join
- Previously operated eyes
- Presence of corneal pathology
- Pseudo exfoliation
- With-the-rule (WTR) astigmatism >1 D
- Presence of diabetes mellitus
- History of connective tissue disease
- Consumption of systemic steroids
Trial locations and contacts
1 site in 1 country.
About this study
To compare the short-term astigmatic outcomes of phacoemulsification cataract surgery and intraocular lens implantation using temporal versus nasal clear corneal incisions.
Read the detailed description
In a clinical trial, consecutive eyes with senile cataract underwent phacoemulsification with implantation of a 6.0 mm foldable hydrophobic acrylic intraocular lens through a 3.2 mm horizontal clear cornea incision at 180 degrees (temporal incision in right eyes, nasal incision in left eyes). Keratometric astigmatism was measured preoperatively and one and four weeks and 6 months after surgery. Surgically induced astigmatism (SIA) was calculated by the vector analysis method using the Holladay-Cravy-Koch formula. Patients with history of diabetes mellitus, connective tissue disorders, steroid use, previous ocular surgery, with the rule astigmatism >1D, pseudoexfoliation and any corneal pathology were excluded.
- Conditions
- Surrgical Induced Astigmatism
- Being tested
- phacoemulsification and intraocular lens implantation
- Keywords
- Kataract, Astigmatism, phacoemulsification
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phacoemulsification and intraocular lens implantationProcedure or surgery
clear cornea phacoemulsification and intraocular lens implantation using temporal or nasal incisions respectively
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Temporal (right eye) Receives: Procedure: phacoemulsification and intraocular lens implantation |
| 2 | Experimental | Nasal (Left eye) Receives: Procedure: phacoemulsification and intraocular lens implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total and Surgical Induced Astigmatism
Measured: At 1 and 4 weeks and 6 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2007 (estimated)
- Study startJun 2005
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surrgical Induced 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 N/A
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Mohammad Pakravan, MD, Principal investigator, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521833
- Sponsor's protocol ID
- 8380
- Status last verified
- Aug 2007
- First submitted
- 27 Aug 2007
- Last updated
- 5 Sep 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgically Induced Astigmatism of Temporal Versus Nasal Clear Corneal Phacoemulsification
- ClinicalTrials.gov ID
- NCT00521833
- Acronym / sponsor ID
- 8380
- Conditions
- Surrgical Induced Astigmatism
- Keywords
- Kataract, Astigmatism, phacoemulsification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2005
- Study completion
- Aug 2006 (actual)
- First posted
- 28 Aug 2007 (estimated)
- 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.
To compare the short-term astigmatic outcomes of phacoemulsification cataract surgery and intraocular lens implantation using temporal versus nasal clear corneal incisions.
Detailed description
In a clinical trial, consecutive eyes with senile cataract underwent phacoemulsification with implantation of a 6.0 mm foldable hydrophobic acrylic intraocular lens through a 3.2 mm horizontal clear cornea incision at 180 degrees (temporal incision in right eyes, nasal incision in left eyes). Keratometric astigmatism was measured preoperatively and one and four weeks and 6 months after surgery. Surgically induced astigmatism (SIA) was calculated by the vector analysis method using the Holladay-Cravy-Koch formula. Patients with history of diabetes mellitus, connective tissue disorders, steroid use, previous ocular surgery, with the rule astigmatism >1D, pseudoexfoliation and any corneal pathology were excluded.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: phacoemulsification and intraocular lens implantationTemporal (right eye) |
| 2 | Experimental | Procedure: phacoemulsification and intraocular lens implantationNasal (Left eye) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All the patients with senile cataract
Key exclusion criteria (7 listed)
- Previously operated eyes
- Presence of corneal pathology
- Pseudo exfoliation
- With-the-rule (WTR) astigmatism >1 D
- Presence of diabetes mellitus
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 |
|---|---|---|
| phacoemulsification and intraocular lens implantationclear cornea phacoemulsification and intraocular lens implantation using temporal or nasal incisions respectively | Procedure or surgery | 1, 2 |
Primary outcome
Total and Surgical Induced Astigmatism
Time frame: At 1 and 4 weeks and 6 month after 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 Sep 2007.
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.
Mohammad Pakravan, MD principal investigator
Shahid Beheshti University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phacoemulsification and intraocular lens implantation in people with Surrgical Induced Astigmatism, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 1 inclusion and 7 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 Sep 2007. 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 Iran. 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?
Total and Surgical Induced Astigmatism (time frame: At 1 and 4 weeks and 6 month after surgery). 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 Sep 2007.