Refractive ErrorNCT04676620
Comparison of Anterior Corneal Optical Aberration Induced by CK and Hyperopic LASIK
An observational study of Refractive Error, run by Wang Hongxia at 1 site in China.
Trial summary
Conductive keratoplasty (CK) had shown to be a safe and effective procedure for the treatment of low to moderate hypeopia. It had been approved by the U.S. Food and Drug Administration (FDA) to treat presbyope in early 2004. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Refractive Error
- What is being tested?
- CK surgery
- Type of treatment
- Surgery or procedure
- How many people
- 69 participants
- Where
- 1 siteChina
- Study dates
- Dec 2020to Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In this consecutive case series, 69 eyes of 57 patients (30 female and 27 male) with hyperopia or presbyopia were enrolled. Inclusion criteria included age of over 40 years old (yrs), stable refraction, and patients who were planned to induce a myopic shift ranging of -1.00 diopters (D) to -2.50D. Mean patient age was 52.9±5.7 yrs (range from 42 to 68 yrs). The ophthalmic examination for each patient included uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA) (Snellen chart), near vision (Jaeger chart), manifest and cycloplegic refraction, videokeratography, central and peripheral corneal ultrasound pachymetry (thickness), slit-lamp microscopy, dilated fundus examinations, IOP.
Who may be able to join
- age of over 40 years old (yrs)
- stable refraction
- planned to induce a myopic shift
Who cannot join
- age of less than 40 years old (yrs)
- significant systemic illnesses
- congenital myopia,
- media opacity uveitis
- glaucoma
- intraocular surgery refractive surgery
- neurologic diseases
- retinal disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Guanghua Integrated Traditional Chinese and Western Medicine Hospital
Shanghai, Shanghai Municipality, 200052
Hongxia Wang, director, 18302183233 ext. 18302183233, whxeye@163.com
About this study
Official title: Comparison of Anterior Corneal Optical Aberration Induced by Conductive Keratoplasty and Hyperopic Laser in Situ Keratomileusis
Conductive keratoplasty (CK) had shown to be a safe and effective procedure for the treatment of low to moderate hypeopia. It had been approved by the U.S. Food and Drug Administration (FDA) to treat presbyope in early 2004. CK appeals to both surgeons and patients as it avoids the need for flap creation, the use of high intraocular pressure (IOP), or tissue ablation. It utilizes "blended vision" rather than the true monovision used with laser in situ keratomileusis (LASIK), which patients tolerate more readily. There is very little reported research about the induction of wavefront aberration by CK. The symptomatology of high order aberrations (HOA) and the way individual Zernike functions were correlated with visual acuity, contrast sensitivity, visual symptoms. This study measured the HOA created by surgically induced myopic shift via CK and LASIK in an effort to better understand the phenomena of regression, multifocality, pseudo-accommodation and monovision.
Read the detailed description
To investigate anterior corneal optical higher order aberration (HOA) induced by conductive keratoplasty (CK) and laser in situ keratomileusis (LASIK). 69 eyes with hyperopia or presbyopia were enrolled. 47 eyes of 47 patients underwent CK procedure, 22 eyes underwent LASIK. Data were acquired preoperatively, and at 3 and 6 months postoperatively. The total Root Mean Square (RMS) of the HOA as well as the individual Zernike polynomials of coma, trefoil, and spherical aberration were analyzed. In CK group, the high order RMS showed significant elevation at 3 months, but it returned to near preoperative levels at 6 months postoperatively. Trefoil (Z33) is the exclusive Zenike pattern to increase significantly following CK, peaking at 3 months and then decreasing back to near preoperative level at 6 months after CK. In the hyperopic LASIK group, coma increased to a peak at 3 month postoperatively, and persisted at sixth month after LASIK. Spherical aberration decreased significantly at 3 months and persisted till the sixth postoperative month. There was significant correlation between ΔSE and Δspherical aberration showed in both groups. The HOA and main Zernike polynomials pattern and their natural changes induced by CK is significantly different from that induced by LASIK in the hyperopic corrected treatment. The amount of achieved hyperopic corrections induced by CK or LASIK is not correlated to the change of HOA patterns such as coma and trefoil, but it is correlated to the change of spherical aberration.
- Conditions
- Refractive Error
- Being tested
- CK surgery
- Keywords
- conductive keratoplasty, corneal optical aberrations, hyperopic corrections, LASIK
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CK surgeryProcedure or surgery
CK and LASIK are both effective methods for the correction of hypeopia. They have been proved to offer many advantages in terms of visual acuity, corneal sensitivity, and corneal biomechanics compared with traditional refractive surgeries.
| Study group | Role | What they receive |
|---|---|---|
| CK surgery | Conductive keratoplasty (CK) had shown to be a safe and effective procedure for the treatment of low to moderate hypeopia. It had been approved by the U.S. Food and Drug Administration (FDA) to treat presbyope in early 2004. CK appeals to both surgeons and patients as it avoids the need for flap creation, the use of high intraocular pressure (IOP), or tissue ablation. Receives: Procedure: CK surgery | |
| LASIK surgery | LASIK surgery is femtosecond laser assisted conventional refractive surgery and has also been proved to offer many advantages in terms of visual acuity, corneal sensitivity, and corneal biomechanics compared with traditional refractive surgeries. Receives: Procedure: CK surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
uncorrected visual acuity
uncorrected visual acuity change from baseline at 6 months
Measured: change from baseline with EDTRS chart at 6 months
best spectacle-corrected visual acuity
best spectacle-corrected visual acuity change from baseline with EDTRS chart at 6 months
Measured: change from baseline with EDTRS chart at 6 months
Secondary outcomes (2)
near vision
near vision change from baseline with EDTRS chart at 6 months
Measured: change from baseline with EDTRS chart at 6 months
central and peripheral corneal ultrasound pachymetry
central and peripheral corneal ultrasound pachymetry change from baseline with EDTRS chart at 6 months
Measured: change from baseline with EDTRS chart at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study startDec 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Refractive ErrorStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wang Hongxia
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Eye Hospital
- Responsible party
- Sponsor-investigator, Wang Hongxia, Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
- Investigators
- Hongxia Wang, director, Study director, Shanghai Guanghua integrated traditional Chinese and Western Medicine Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676620
- Sponsor's protocol ID
- 2020-K-107
- Status last verified
- Dec 2020
- First submitted
- 15 Dec 2020
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Du TT, Fan VC, Asbell PA. Conductive keratoplasty. Curr Opin Ophthalmol. 2007 Jul;18(4):334-7. doi: 10.1097/ICU.0b013e3281df2cf0.
PubMed 17568211Lin DY, Manche EE. Two-year results of conductive keratoplasty for the correction of low to moderate hyperopia. J Cataract Refract Surg. 2003 Dec;29(12):2339-50. doi: 10.1016/j.jcrs.2003.09.022.
PubMed 14709295Pallikaris lG, Naoumidi TL, Panagopoulou SI, Alegakis AK, Astyrakakis NI. Conductive keratoplasty for low to moderate hyperopia: 1-year results. J Refract Surg. 2003 Sep-Oct;19(5):496-506. doi: 10.3928/1081-597X-20030901-04.
PubMed 14518738
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Anterior Corneal Optical Aberration Induced by Conductive Keratoplasty and Hyperopic Laser in Situ Keratomileusis
- ClinicalTrials.gov ID
- NCT04676620
- Acronym / sponsor ID
- 2020-K-107
- Conditions
- Refractive Error
- Keywords
- conductive keratoplasty, corneal optical aberrations, hyperopic corrections, LASIK
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Wang HongxiaUniversity, hospital or other
- Collaborators
- Tianjin Eye Hospital
- Study start
- Dec 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 21 Dec 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.
Conductive keratoplasty (CK) had shown to be a safe and effective procedure for the treatment of low to moderate hypeopia. It had been approved by the U.S. Food and Drug Administration (FDA) to treat presbyope in early 2004. CK appeals to both surgeons and patients as it avoids the need for flap creation, the use of high intraocular pressure (IOP), or tissue ablation. It utilizes "blended vision" rather than the true monovision used with laser in situ keratomileusis (LASIK), which patients tolerate more readily. There is very little reported research about the induction of wavefront aberration by CK. The symptomatology of high order aberrations (HOA) and the way individual Zernike functions were correlated with visual acuity, contrast sensitivity, visual symptoms. This study measured the HOA created by surgically induced myopic shift via CK and LASIK in an effort to better understand the phenomena of regression, multifocality, pseudo-accommodation and monovision.
Detailed description
To investigate anterior corneal optical higher order aberration (HOA) induced by conductive keratoplasty (CK) and laser in situ keratomileusis (LASIK). 69 eyes with hyperopia or presbyopia were enrolled. 47 eyes of 47 patients underwent CK procedure, 22 eyes underwent LASIK. Data were acquired preoperatively, and at 3 and 6 months postoperatively. The total Root Mean Square (RMS) of the HOA as well as the individual Zernike polynomials of coma, trefoil, and spherical aberration were analyzed. In CK group, the high order RMS showed significant elevation at 3 months, but it returned to near preoperative levels at 6 months postoperatively. Trefoil (Z33) is the exclusive Zenike pattern to increase significantly following CK, peaking at 3 months and then decreasing back to near preoperative level at 6 months after CK. In the hyperopic LASIK group, coma increased to a peak at 3 month postoperatively, and persisted at sixth month after LASIK. Spherical aberration decreased significantly at 3 months and persisted till the sixth postoperative month. There was significant correlation between ΔSE and Δspherical aberration showed in both groups. The HOA and main Zernike polynomials pattern and their natural changes induced by CK is significantly different from that induced by LASIK in the hyperopic corrected treatment. The amount of achieved hyperopic corrections induced by CK or LASIK is not correlated to the change of HOA patterns such as coma and trefoil, but it is correlated to the change of spherical aberration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CK surgery | – | Procedure: CK surgeryConductive keratoplasty (CK) had shown to be a safe and effective procedure for the treatment of low to moderate hypeopia. It had been approved by the U.S. Food and Drug Administration (FDA) to treat presbyope in early 2004. CK appeals to both surgeons and patients as it avoids the need for flap creation, the use of high intraocular pressure (IOP), or tissue ablation. |
| LASIK surgery | – | Procedure: CK surgeryLASIK surgery is femtosecond laser assisted conventional refractive surgery and has also been proved to offer many advantages in terms of visual acuity, corneal sensitivity, and corneal biomechanics compared with traditional refractive surgeries. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this consecutive case series, 69 eyes of 57 patients (30 female and 27 male) with hyperopia or presbyopia were enrolled. Inclusion criteria included age of over 40 years old (yrs), stable refraction, and patients who were planned to induce a myopic shift ranging of -1.00 diopters (D) to -2.50D. Mean patient age was 52.9±5.7 yrs (range from 42 to 68 yrs). The ophthalmic examination for each patient included uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA) (Snellen chart), near vision (Jaeger chart), manifest and cycloplegic refraction, videokeratography, central and peripheral corneal ultrasound pachymetry (thickness), slit-lamp microscopy, dilated fundus examinations, IOP.
Key inclusion criteria (3 listed)
- age of over 40 years old (yrs)
- stable refraction
- planned to induce a myopic shift
Key exclusion criteria (8 listed)
- age of less than 40 years old (yrs)
- significant systemic illnesses
- congenital myopia,
- media opacity uveitis
- glaucoma
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 |
|---|---|---|
| CK surgeryCK and LASIK are both effective methods for the correction of hypeopia. They have been proved to offer many advantages in terms of visual acuity, corneal sensitivity, and corneal biomechanics compared with traditional refractive surgeries. | Procedure or surgery | CK surgery, LASIK surgery |
Primary outcome
uncorrected visual acuity
Time frame: change from baseline with EDTRS chart at 6 months
uncorrected visual acuity change from baseline at 6 months
best spectacle-corrected visual acuity
Time frame: change from baseline with EDTRS chart at 6 months
best spectacle-corrected visual acuity change from baseline with EDTRS chart at 6 months
2 secondary outcomes
near vision
Time frame: change from baseline with EDTRS chart at 6 months
central and peripheral corneal ultrasound pachymetry
Time frame: change from baseline with EDTRS chart at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Results publication: PubMed 17568211Du TT, Fan VC, Asbell PA. Conductive keratoplasty. Curr Opin Ophthalmol. 2007 Jul;18(4):334-7. doi: 10.1097/ICU.0b013e3281df2cf0.
- Results publication: PubMed 14709295Lin DY, Manche EE. Two-year results of conductive keratoplasty for the correction of low to moderate hyperopia. J Cataract Refract Surg. 2003 Dec;29(12):2339-50. doi: 10.1016/j.jcrs.2003.09.022.
- Results publication: PubMed 14518738Pallikaris lG, Naoumidi TL, Panagopoulou SI, Alegakis AK, Astyrakakis NI. Conductive keratoplasty for low to moderate hyperopia: 1-year results. J Refract Surg. 2003 Sep-Oct;19(5):496-506. doi: 10.3928/1081-597X-20030901-04.
- Individual participant dataSharing planned: No
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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.
Hongxia Wang, director study director
Shanghai Guanghua integrated traditional Chinese and Western Medicine 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 Refractive Error, run by Wang Hongxia at 1 site in China.
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 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: status not confirmed, as of the sponsor's last update on 21 Dec 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 China. 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 Hongxia Wang, director (18302183233, whxeye@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
uncorrected visual acuity (time frame: change from baseline with EDTRS chart at 6 months). 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?
On the ClinicalTrials.gov record for NCT04676620, which also lists 3 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 21 Dec 2020.