Cataract ExtractionNCT00466908
Accuracy of the Pentacam and IOL Master to Calculate the Effective Corneal Power After Corneal Refractive Surgery
An observational study of Cataract Extraction and Refractive Surgery, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to determine the accuracy of the Pentacam and IOL Master to calculate the effective corneal power (keratometry, corneal curvature) in patients who have undergone both corneal refractive surgery and lens extraction with intraocular lens implantation. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cataract Extraction, Refractive Surgery
- What is being tested?
- Pentacam and IOL Master
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Aug 2007
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subject must have undergone corneal refractive surgery (RK, PRK or LASIK) prior to cataract extraction. Age: 40 to 80 years old.
Who may be able to join
- Subject must have undergone corneal refractive surgery (RK, PRK or LASIK) prior to cataract extraction.
- Age: 40 to 80 years old.
- Subjects must have undergone cataract extraction at least 4 weeks prior to enrollment in this trial.
- Willing and able to comply with scheduled visits and other study procedures.
Who cannot join
- Preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphtalmus or macrophtalmus, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.
- Uncontrolled diabetes.
- Use of any systemic or topical drug known to interfere with visual performance.
- Contact lens use during the active treatment portion of the trial.
- Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis.
- Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or study device implantation or may interfere with the interpretation of study results.
- Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.
- Intraocular conventional surgery (other than cataract extraction) within the past three months or intraocular laser surgery within one month in the operated eye.
Trial locations and contacts
1 site in 1 country.
United States1 site
Storm Eye Institute, Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
The purpose of this study is to determine the accuracy of the Pentacam and IOL Master to calculate the effective corneal power (keratometry, corneal curvature) in patients who have undergone both corneal refractive surgery and lens extraction with intraocular lens implantation.
Read the detailed description
The accuracy of IOL calculation is important for the visual outcome of patients undergoing cataract extraction and IOL implantation. Different formulas such as Holladay I, HofferQ, SRKT have been used with excellent results. All formulas use the corneal power among other factors to calculate the IOL power. Corneal refractive surgery i.e. radial keratotomy (RK), photorefractive keratectomy (PRK), and Laser in situ keratomileusis (LASIK) changes the corneal power; therefore, it is difficult to measure the true corneal power after surgery by any form of direct measurement, such as keratometry, or corneal topography. Keratometry and topography assume a normal relationship between the anterior and posterior corneal curvatures, and measure the anterior corneal radius. RK for myopia flattens both the anterior corneal radius and the posterior corneal radius while PRK and LASIK for myopia flattens the anterior corneal radius but leaves the posterior corneal radius mostly unchanged.
Standard keratometry measures an intermediate area and extrapolates the central power based on some very broad assumptions. For this reason, keratometry, autokeratometry and simulated keratometry by topography will typically over-estimate central corneal power following keratorefractive surgery for myopia. This inaccuracy leads to an inability to meet the patients' rising expectations and with the increasing popularity of refractive surgery, calculating intraocular lens (IOL) power after refractive surgery is becoming increasingly important.
Different methods to calculate the effective corneal power (keratometry) after refractive surgery have been described (historical data, effective refractive power, modified Maloney method, etc), however, intraocular lens power calculations in eyes with previous refractive surgery remains difficult because of the inaccuracy of keratometry power measurements.
The Pentacam (Comprehensive Eye Scanner) is a non-invasive, diagnostic system created to take photographs of the anterior segment of the eye by a rotating Scheimpflug camera measurement. This rotating process supplies pictures in three dimensions. The center of the cornea is measured very precisely because of this rotational imaging process. The measurement process lasts less than two seconds and minute eye movements are captured and corrected simultaneously. By measuring 25,000 true elevation points, precise representation, repeatability and analysis are guaranteed. It provides a topographic analysis of the corneal front and back surfaces that is based on the true elevation measurement from limbus to limbus. Both corneal surfaces can be selected for analysis in axial (sagittal), tangential or elevation representation modes.
The Pentacam using tomography calculates a virtual model of the anterior segment of the eye. It is possible to move, zoom and rotate it to detect e.g. iris defects, cornea incisions e.g. RK or size, location and shape of opacifications in the crystalline lens. The slicing function in the three dimensions offers a detailed view of the different layers of the eye. It includes the Holladay report that was developed to improve the calculation of IOLs for patients which have undergone corneal refractive surgery.
The IOL Master is a non-contact optical coherence biometry that makes possible the exact measurement of visual axis length. Its accuracy is not affected by high ametropia, pupil size or state of accommodation. This non-contact technology makes it easy on the patient: no local anesthesia, water bath, or contact probe. For IOL power calculation after previous refractive corneal surgery, one can derive the effective corneal power using either the clinical history method, or the rigid contact lens over-refraction method. It therefore permits selection of a suitable lens after myopic LASIK/PRK without requiring refractive pre-LASIK data or additional contact lens over-refraction.
The purpose of this study is to determine the accuracy of the Pentacam and IOL Master to calculate the effective corneal power (keratometry, corneal curvature) in patients who have undergone both corneal refractive surgery and lens extraction with intraocular lens implantation.
- Conditions
- Cataract Extraction, Refractive Surgery
- Being tested
- Pentacam and IOL Master
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentacam and IOL MasterDevice
Pentacam and IOL Master
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startMar 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract ExtractionStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Investigators
- Helga Sandoval, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00466908
- Sponsor's protocol ID
- MRC-07-001
- Status last verified
- Oct 2010
- First submitted
- 25 Apr 2007
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of the Pentacam and IOL Master to Calculate the Effective Corneal Power After Corneal Refractive Surgery
- ClinicalTrials.gov ID
- NCT00466908
- Acronym / sponsor ID
- MRC-07-001
- Conditions
- Cataract Extraction, Refractive Surgery
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Mar 2007
- Study completion
- Aug 2007 (actual)
- First posted
- 27 Apr 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.
The purpose of this study is to determine the accuracy of the Pentacam and IOL Master to calculate the effective corneal power (keratometry, corneal curvature) in patients who have undergone both corneal refractive surgery and lens extraction with intraocular lens implantation.
Detailed description
The accuracy of IOL calculation is important for the visual outcome of patients undergoing cataract extraction and IOL implantation. Different formulas such as Holladay I, HofferQ, SRKT have been used with excellent results. All formulas use the corneal power among other factors to calculate the IOL power. Corneal refractive surgery i.e. radial keratotomy (RK), photorefractive keratectomy (PRK), and Laser in situ keratomileusis (LASIK) changes the corneal power; therefore, it is difficult to measure the true corneal power after surgery by any form of direct measurement, such as keratometry, or corneal topography. Keratometry and topography assume a normal relationship between the anterior and posterior corneal curvatures, and measure the anterior corneal radius. RK for myopia flattens both the anterior corneal radius and the posterior corneal radius while PRK and LASIK for myopia flattens the anterior corneal radius but leaves the posterior corneal radius mostly unchanged.
Standard keratometry measures an intermediate area and extrapolates the central power based on some very broad assumptions. For this reason, keratometry, autokeratometry and simulated keratometry by topography will typically over-estimate central corneal power following keratorefractive surgery for myopia. This inaccuracy leads to an inability to meet the patients' rising expectations and with the increasing popularity of refractive surgery, calculating intraocular lens (IOL) power after refractive surgery is becoming increasingly important.
Different methods to calculate the effective corneal power (keratometry) after refractive surgery have been described (historical data, effective refractive power, modified Maloney method, etc), however, intraocular lens power calculations in eyes with previous refractive surgery remains difficult because of the inaccuracy of keratometry power measurements.
The Pentacam (Comprehensive Eye Scanner) is a non-invasive, diagnostic system created to take photographs of the anterior segment of the eye by a rotating Scheimpflug camera measurement. This rotating process supplies pictures in three dimensions. The center of the cornea is measured very precisely because of this rotational imaging process. The measurement process lasts less than two seconds and minute eye movements are captured and corrected simultaneously. By measuring 25,000 true elevation points, precise representation, repeatability and analysis are guaranteed. It provides a topographic analysis of the corneal front and back surfaces that is based on the true elevation measurement from limbus to limbus. Both corneal surfaces can be selected for analysis in axial (sagittal), tangential or elevation representation modes.
The Pentacam using tomography calculates a virtual model of the anterior segment of the eye. It is possible to move, zoom and rotate it to detect e.g. iris defects, cornea incisions e.g. RK or size, location and shape of opacifications in the crystalline lens. The slicing function in the three dimensions offers a detailed view of the different layers of the eye. It includes the Holladay report that was developed to improve the calculation of IOLs for patients which have undergone corneal refractive surgery.
The IOL Master is a non-contact optical coherence biometry that makes possible the exact measurement of visual axis length. Its accuracy is not affected by high ametropia, pupil size or state of accommodation. This non-contact technology makes it easy on the patient: no local anesthesia, water bath, or contact probe. For IOL power calculation after previous refractive corneal surgery, one can derive the effective corneal power using either the clinical history method, or the rigid contact lens over-refraction method. It therefore permits selection of a suitable lens after myopic LASIK/PRK without requiring refractive pre-LASIK data or additional contact lens over-refraction.
The purpose of this study is to determine the accuracy of the Pentacam and IOL Master to calculate the effective corneal power (keratometry, corneal curvature) in patients who have undergone both corneal refractive surgery and lens extraction with intraocular lens implantation.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject must have undergone corneal refractive surgery (RK, PRK or LASIK) prior to cataract extraction. Age: 40 to 80 years old.
Key inclusion criteria (4 listed)
- Subject must have undergone corneal refractive surgery (RK, PRK or LASIK) prior to cataract extraction.
- Age: 40 to 80 years old.
- Subjects must have undergone cataract extraction at least 4 weeks prior to enrollment in this trial.
- Willing and able to comply with scheduled visits and other study procedures.
Key exclusion criteria (8 listed)
- Preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphtalmus or macrophtalmus, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.
- Uncontrolled diabetes.
- Use of any systemic or topical drug known to interfere with visual performance.
- Contact lens use during the active treatment portion of the trial.
- Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis.
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 |
|---|---|---|
| Pentacam and IOL MasterPentacam and IOL Master | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
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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.
Helga Sandoval, MD principal investigator
Medical University of South Carolina
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 Extraction and Refractive Surgery, run by Medical University of South Carolina at 1 site in United States.
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 8 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: withdrawn, as of the sponsor's last update on 6 Jun 2018. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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.
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 6 Jun 2018.