HyperopiaNCT03224013
Hyperopic LASIK With Crosslinking Versus Standard LASIK
A study testing LASIK in people with Hyperopia, run by Minia University.
Trial summary
Analysis corneal and refractive stability of hyperopic laser-assisted in situ keratomileusis (LASIK) with and without concurrent prophylactic high-fluence cross-linking (CXL). Read more about this study
- Who is it for?
- Ages 18 to 61 years
- Conditions the study is for
- Hyperopia
- What is being tested?
- LASIK
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 18 Jan 2016to 12 Jul 2017
- 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 18 to 61 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Cases with hyperopia +1diopter to +6 diopters or hyperopic astigmatism up to 4 diopters
Who cannot join
- Patients with previous intraocular or corneal surgery, active corneal disease
About this study
Official title: Hyperopic LASIK With Concurrent Prophylactic High-fluence Cross-linking Versus Standard LASIK Outcomes
Analysis corneal and refractive stability of hyperopic laser-assisted in situ keratomileusis (LASIK) with and without concurrent prophylactic high-fluence cross-linking (CXL).
Read the detailed description
Interventional prospective consecutive comparative case control series of cases; 50 eyes of 25 patients with mean age 35.7 ± 12.4 (Range 18-61years) with hyperopia or hyperopic astigmatism underwent customized LASIK with concurrent prophylactic high-fluence cross-linking in right eye (group 1) and customized LASIK only in left eye (group 2). Cases with hyperopia +1 diopter to +6 diopters or hyperopic astigmatism up to 4 diopters were included in the study. Patients with previous intraocular or corneal surgery, active corneal disease were excluded from the study.
Main outcome measures were uncorrected visual acuity (UCVA), manifest refractive spherical equivalent (MRSE), cycloplegic refractive spherical equivalent (CRSE), keratometric measurements and spherical aberrations at 4 mm and maximum pupil and their evolution along 6 months postoperatively.
- Conditions
- Hyperopia
- Being tested
- LASIK
- Medical subject headings
- Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LASIKProcedure or surgery
LASIK with concurrent prophylactic high fluence crosslinking in right eye ( After the excimer laser ablation, and with the flap folded onto itself and protected with a dry sponge, one drop of Vibex Rapid™ , consisting of 0.10% saline-diluted riboflavin (a very slightly hypotonic solution, mixed with hydroxypropyl methylcellulose, a dextran substitute), was placed on the exposed stromal bed afforded by the open LASIK flap and carefully spread over the bed area with an irrigating cannula for 60 seconds and LASIK only in left eye
| Study group | Role | What they receive |
|---|---|---|
| Hyperopic LASIK with crosslinking | Active comparator | group 1:hyperopic customized LASIK with concurrent prophylactic high-fluence cross-linking Receives: Procedure: LASIK |
| Hyperopic LASIK only | Active comparator | group 2: hyperopic customized LASIK only Receives: Procedure: LASIK |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of changes in refractive spherical equivalent
assessment of changes in manifest refraction by autorefractometer and then calculate spherical equivalent
Measured: preoperative and 3 months and 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start18 Jan 2016
- Primary completion12 May 2017
- Study completion12 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperopiaStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Interventional prospective consecutive comparative case control series of cases; 50 eyes of 25 patients with mean age 35.7 ± 12.4 (Range 18-61years) with hyperopia or hyperopic astigmatism underwent customized LASIK with concurrent prophylactic high-fluence cross-linking in right eye (group 1) and customized LASIK only in left eye (group 2). Cases with hyperopia +1D to +6D or hyperopic astigmatism up to 4D were included in the study. Patients with previous intraocular or corneal surgery, active corneal disease were excluded from the study. Main outcome measures were uncorrected visual acuity (UCVA), manifest refractive spherical equivalent (MRSE), cycloplegic refractive spherical equivalent (CRSE), keratometric measurments and spherical aberrations at 4 mm and maximum pupilnand their ecolution along 6 months postoperatively.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahemd Abdelghany, Minia University
- Investigators
- Jorge L Alio, MD, Study director, MD, Phd, FEBO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224013
- Sponsor's protocol ID
- Hyperopic LASIK
- Status last verified
- Jul 2017
- First submitted
- 15 Jul 2017
- Last updated
- 21 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperopic LASIK With Concurrent Prophylactic High-fluence Cross-linking Versus Standard LASIK Outcomes
- ClinicalTrials.gov ID
- NCT03224013
- Acronym / sponsor ID
- Hyperopic LASIK
- Conditions
- Hyperopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 18 Jan 2016 (actual)
- Primary completion
- 12 May 2017 (actual)
- Study completion
- 12 Jul 2017 (actual)
- First posted
- 21 Jul 2017 (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.
Analysis corneal and refractive stability of hyperopic laser-assisted in situ keratomileusis (LASIK) with and without concurrent prophylactic high-fluence cross-linking (CXL).
Detailed description
Interventional prospective consecutive comparative case control series of cases; 50 eyes of 25 patients with mean age 35.7 ± 12.4 (Range 18-61years) with hyperopia or hyperopic astigmatism underwent customized LASIK with concurrent prophylactic high-fluence cross-linking in right eye (group 1) and customized LASIK only in left eye (group 2). Cases with hyperopia +1 diopter to +6 diopters or hyperopic astigmatism up to 4 diopters were included in the study. Patients with previous intraocular or corneal surgery, active corneal disease were excluded from the study.
Main outcome measures were uncorrected visual acuity (UCVA), manifest refractive spherical equivalent (MRSE), cycloplegic refractive spherical equivalent (CRSE), keratometric measurements and spherical aberrations at 4 mm and maximum pupil and their evolution along 6 months postoperatively.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional prospective consecutive comparative case control series of cases; 50 eyes of 25 patients with mean age 35.7 ± 12.4 (Range 18-61years) with hyperopia or hyperopic astigmatism underwent customized LASIK with concurrent prophylactic high-fluence cross-linking in right eye (group 1) and customized LASIK only in left eye (group 2). Cases with hyperopia +1D to +6D or hyperopic astigmatism up to 4D were included in the study. Patients with previous intraocular or corneal surgery, active corneal disease were excluded from the study. Main outcome measures were uncorrected visual acuity (UCVA), manifest refractive spherical equivalent (MRSE), cycloplegic refractive spherical equivalent (CRSE), keratometric measurments and spherical aberrations at 4 mm and maximum pupilnand their ecolution along 6 months postoperatively.
| Arm | Type | Receives |
|---|---|---|
| Hyperopic LASIK with crosslinking | Active comparator | Procedure: LASIKgroup 1:hyperopic customized LASIK with concurrent prophylactic high-fluence cross-linking |
| Hyperopic LASIK only | Active comparator | Procedure: LASIKgroup 2: hyperopic customized LASIK only |
Who may qualify
- Ages
- 18 to 61 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Cases with hyperopia +1diopter to +6 diopters or hyperopic astigmatism up to 4 diopters
Key exclusion criteria (1 listed)
- Patients with previous intraocular or corneal surgery, active corneal disease
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 |
|---|---|---|
| LASIKLASIK with concurrent prophylactic high fluence crosslinking in right eye ( After the excimer laser ablation, and with the flap folded onto itself and protected with a dry sponge, one drop of Vibex Rapid™ , consisting of 0.10% saline-diluted riboflavin (a very slightly hypotonic solution, mixed with hydroxypropyl methylcellulose, a dextran substitute), was placed on the exposed stromal bed afforded by the open LASIK flap and carefully spread over the bed area with an irrigating cannula for 60 seconds and LASIK only in left eye | Procedure or surgery | Hyperopic LASIK only, Hyperopic LASIK with crosslinking |
Primary outcome
assessment of changes in refractive spherical equivalent
Time frame: preoperative and 3 months and 6 months postoperative
assessment of changes in manifest refraction by autorefractometer and then calculate spherical equivalent
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 21 Jul 2017.
- Individual participant dataSharing planned: No
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School-based Myopia Prevention Trial for Children With Insufficient Hyperopic Reserve
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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.
Jorge L Alio, MD study director
MD, Phd, FEBO
Questions about this trial
What is this clinical trial studying?
A study testing LASIK in people with Hyperopia, run by Minia University.
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 1 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 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
assessment of changes in refractive spherical equivalent (time frame: preoperative and 3 months and 6 months postoperative). 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 21 Jul 2017.