CataractCINPHANCT00742950
Refractive Change Induced by 2.8-mm Corneal Incision
A study testing Nasal 2.8-mm corneal incision, Temporal 2.8-mm corneal incision and Superior 2.8-mm incision in people with Cataract and Refractive Surgery, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial summary
The investigators' purpose is to study the induced refractive change caused by different 2.8-mm corneal incision locations in phacoemulsification, because the investigators hypothesize that the effect may be different for nasal, temporal, and superior location, although they are considered astigmatism neutral. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Cataract, Refractive Surgery, Astigmatism
- What is being tested?
- Nasal 2.8-mm corneal incision, Temporal 2.8-mm corneal incision and Superior 2.8-mm incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2008to Dec 2009
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Visual impairment for daily tasks caused by cataract
- Age older than 50 years
- Steep axis of corneal astigmatism at 90° ± 20° or 180° ± 20°
- Ability to cooperate in the protocol procedures
Who cannot join
- Age below 50
- Inability to cooperate with measurements
Trial locations and contacts
1 site in 1 country.
Spain1 site
Dept Ophthalmology, Hospital Universitario Ramón y Cajal
Madrid, Madrid, 28034
About this study
Official title: Study of Refractive Change Induced by 2.8-mm Corneal Incisions for Cataract Surgery
The investigators' purpose is to study the induced refractive change caused by different 2.8-mm corneal incision locations in phacoemulsification, because the investigators hypothesize that the effect may be different for nasal, temporal, and superior location, although they are considered astigmatism neutral.
Patients will be randomized to nasal or temporal incision, or assigned to superior incision, depending on preexisting astigmatism. Visual acuity, refraction, keratometry, Pentacam analysis, intraocular pressure, biomicroscopy, and funduscopy, will be carried out before and after phacoemulsification.
Outcome measures will be induced corneal refractive change (Fourier power vector analysis), ISV change, and visual acuity, at 6 months.
- Conditions
- Cataract, Refractive Surgery, Astigmatism
- Being tested
- Nasal 2.8-mm corneal incision, Temporal 2.8-mm corneal incision, Superior 2.8-mm incision
- Keywords
- Corneal incision, Cataract surgery, Phacoemulsification, Surgically induced astigmatism, Corneal Topography
- Medical subject headings
- Cataract, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal 2.8-mm corneal incisionProcedure or surgery
Also called Phacoemulsification nasal incision
Phacoemulsification through a nasal 2.8-mm incision
Temporal 2.8-mm corneal incisionProcedure or surgery
Also called Phacoemulsification temporal incision
Phacoemulsification through a 2.8-mm temporal incision
Superior 2.8-mm incisionProcedure or surgery
Also called Phacoemulsification superior incision
Phacoemulsification through a superior 2.8-mm corneal incision
| Study group | Role | What they receive |
|---|---|---|
| I | Active comparator | Nasal 2.8-mm corneal incision Receives: Procedure: Nasal 2.8-mm corneal incision |
| II | Active comparator | Temporal 2.8-mm corneal incision Receives: Procedure: Temporal 2.8-mm corneal incision |
| III | Active comparator | Superior 2.8-mm corneal incision Receives: Procedure: Superior 2.8-mm incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induced corneal refractive change
Measured: 6 months
Secondary outcomes (2)
ISV change
Measured: 6 months
Visual acuity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionSep 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CataractStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Investigators
- Jaime Tejedor, MD, PhD, Principal investigator, Dept OphthalmologyJosé A Pérez-Rodríguez, MD, Study chair, Dept Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00742950
- Sponsor's protocol ID
- CINPHACO
- Acronym
- CINPHA
- Status last verified
- May 2010
- First submitted
- 26 Aug 2008
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tejedor J, Murube J. Choosing the location of corneal incision based on preexisting astigmatism in phacoemulsification. Am J Ophthalmol. 2005 May;139(5):767-76. doi: 10.1016/j.ajo.2004.12.057.
PubMed 15860279Tejedor J, Perez-Rodriguez JA. Astigmatic change induced by 2.8-mm corneal incisions for cataract surgery. Invest Ophthalmol Vis Sci. 2009 Mar;50(3):989-94. doi: 10.1167/iovs.08-2778. Epub 2008 Nov 14.
PubMed 19011013
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Refractive Change Induced by 2.8-mm Corneal Incisions for Cataract Surgery
- ClinicalTrials.gov ID
- NCT00742950
- Acronym / sponsor ID
- CINPHA / CINPHACO
- Conditions
- Cataract, Refractive Surgery, Astigmatism
- Keywords
- Corneal incision, Cataract surgery, Phacoemulsification, Surgically induced astigmatism, Corneal Topography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 28 Aug 2008 (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.
The investigators' purpose is to study the induced refractive change caused by different 2.8-mm corneal incision locations in phacoemulsification, because the investigators hypothesize that the effect may be different for nasal, temporal, and superior location, although they are considered astigmatism neutral.
Patients will be randomized to nasal or temporal incision, or assigned to superior incision, depending on preexisting astigmatism. Visual acuity, refraction, keratometry, Pentacam analysis, intraocular pressure, biomicroscopy, and funduscopy, will be carried out before and after phacoemulsification.
Outcome measures will be induced corneal refractive change (Fourier power vector analysis), ISV change, and visual acuity, at 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| I | Active comparator | Procedure: Nasal 2.8-mm corneal incisionNasal 2.8-mm corneal incision |
| II | Active comparator | Procedure: Temporal 2.8-mm corneal incisionTemporal 2.8-mm corneal incision |
| III | Active comparator | Procedure: Superior 2.8-mm incisionSuperior 2.8-mm corneal incision |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Visual impairment for daily tasks caused by cataract
- Age older than 50 years
- Steep axis of corneal astigmatism at 90° ± 20° or 180° ± 20°
- Ability to cooperate in the protocol procedures
Key exclusion criteria (2 listed)
- Age below 50
- Inability to cooperate with measurements
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 |
|---|---|---|
| Nasal 2.8-mm corneal incisionAlso: Phacoemulsification nasal incisionPhacoemulsification through a nasal 2.8-mm incision | Procedure or surgery | I |
| Temporal 2.8-mm corneal incisionAlso: Phacoemulsification temporal incisionPhacoemulsification through a 2.8-mm temporal incision | Procedure or surgery | II |
| Superior 2.8-mm incisionAlso: Phacoemulsification superior incisionPhacoemulsification through a superior 2.8-mm corneal incision | Procedure or surgery | III |
Primary outcome
Induced corneal refractive change
Time frame: 6 months
2 secondary outcomes
ISV change
Time frame: 6 months
Visual acuity
Time frame: 6 months
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 27 Jun 2011.
- Background: PubMed 15860279Tejedor J, Murube J. Choosing the location of corneal incision based on preexisting astigmatism in phacoemulsification. Am J Ophthalmol. 2005 May;139(5):767-76. doi: 10.1016/j.ajo.2004.12.057.
- Derived from this study: PubMed 19011013Tejedor J, Perez-Rodriguez JA. Astigmatic change induced by 2.8-mm corneal incisions for cataract surgery. Invest Ophthalmol Vis Sci. 2009 Mar;50(3):989-94. doi: 10.1167/iovs.08-2778. Epub 2008 Nov 14.
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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.
Jaime Tejedor, MD, PhD principal investigator
Dept Ophthalmology
José A Pérez-Rodríguez, MD study chair
Dept Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal 2.8-mm corneal incision, Temporal 2.8-mm corneal incision and Superior 2.8-mm incision in people with Cataract and Refractive Surgery, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
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 2 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 27 Jun 2011. 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 Spain. 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?
Induced corneal refractive change (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00742950, which also lists 2 linked publications.
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 27 Jun 2011.