CataractNCT01979172
Comparison of Intraocular Lens Power Calculation Methods After Corneal Laser Refractive Surgery in Axial and Refractive Ammertropia
An observational study of Cataract and Refractive Errors, run by The National Eye Hospital, Cairo, Egypt at 1 site in Egypt.
Trial summary
The study aims at determining the best biometry calculation formula to be used in IOL calculation of cataract patients how previously underwent laser refractive correction surgery Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cataract, Refractive Errors
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2013to Mar 2014
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patient undergoing laser refractive surgery
Who may be able to join
- all patient undergoing laser refractive surgery
Who cannot join
- previous ophthalmic surgery
- previous trauma
- ocular pathology other than refractive error
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Watany Eye Hopsital
Cairo, Cairo Governorate
Mohamed O El Bahrawy, MS, +201224609383, bahrawy.mohamed@gmail.com
Ahmed Assaf, MD/FRCS
About this study
The study aims at determining the best biometry calculation formula to be used in IOL calculation of cataract patients how previously underwent laser refractive correction surgery
Read the detailed description
Patients undergoing laser refractive surgery will will be investigated in means of Pentacam testing and IOL master biometry both preoperative and 6 weeks postoperative to determine which IOL calculation formula is the nearest and most accurate to preoperative records in different refractive sittings.
- Conditions
- Cataract, Refractive Errors
- Keywords
- LASIK, Intraocular lens, Biometry, IOL master
- Medical subject headings
- Cataract, Refractive Errors
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Selected IOL calculation formula
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionMar 2014 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The National Eye Hospital, Cairo, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed El Bahrawy, The National Eye Hospital, Cairo, Egypt
- Investigators
- Rami R Fikry, MD/FRCS, Principal investigator, Watany Eye HospitalAhmed Assaf, MD/FRCS, Study director, Watany Eye HospitalAhmed Osama, MS, Principal investigator, Watany Eye HospitalMoahmed O El Bahrawy, MS, Principal investigator, Watany Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979172
- Sponsor's protocol ID
- LASIK/IOL
- Status last verified
- Nov 2013
- First submitted
- 3 Nov 2013
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intraocular Lens Power Calculation Methods After Corneal Laser Refractive Surgery in Axial and Refractive Ammertropia
- ClinicalTrials.gov ID
- NCT01979172
- Acronym / sponsor ID
- LASIK/IOL
- Conditions
- Cataract, Refractive Errors
- Keywords
- LASIK, Intraocular lens, Biometry, IOL master
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- The National Eye Hospital, Cairo, EgyptUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 8 Nov 2013 (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 study aims at determining the best biometry calculation formula to be used in IOL calculation of cataract patients how previously underwent laser refractive correction surgery
Detailed description
Patients undergoing laser refractive surgery will will be investigated in means of Pentacam testing and IOL master biometry both preoperative and 6 weeks postoperative to determine which IOL calculation formula is the nearest and most accurate to preoperative records in different refractive sittings.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient undergoing laser refractive surgery
Key inclusion criteria (1 listed)
- all patient undergoing laser refractive surgery
Key exclusion criteria (3 listed)
- previous ophthalmic surgery
- previous trauma
- ocular pathology other than refractive error
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Best Selected IOL calculation formula
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2013.
- Watany Eye Hospital Official websiteLink provided by the sponsor.
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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.
Rami R Fikry, MD/FRCS principal investigator
Watany Eye Hospital
Ahmed Assaf, MD/FRCS study director
Watany Eye Hospital
Ahmed Osama, MS principal investigator
Watany Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and Refractive Errors, run by The National Eye Hospital, Cairo, Egypt at 1 site in Egypt.
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 3 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 8 Nov 2013. 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 Egypt. 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?
Contact mohamed O El Bahrawy, MS (+201224609383, bahrawy.mohamed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Selected IOL calculation formula (time frame: 6 weeks). 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 8 Nov 2013.