Refractive and Accommodative DisordersRCYAGNCT02993081
Capsulotomy YAG Laser
An observational study of Refractive and Accommodative Disorders, run by Instituto de Olhos de Goiania.
Trial summary
Study of refractive changes after capsulotomy with YAG laser in facectomized patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Refractive and Accommodative Disorders
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Nov 2016
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: We studied 67 eyes of 66 patients , both men and women by analyzing the medical records of a reference ophthalmologic hospital in Goiás.
Who may be able to join
None listed.
Who cannot join
- -
About this study
Official title: REFRACTIVE CHANGES AFTER CAPSULOTOMY WITH YAG LASER
Study of refractive changes after capsulotomy with YAG laser in facectomized patients.
Read the detailed description
A retrospective, quantitative study was carried out by analyzing the medical records of a reference ophthalmologic hospital in Goiás. Data from the pre and post YAG laser refractive index data were collected from 67 eyes of 66 patients analyzed in the period from May to November 2016.
We studied 67 eyes of 66 patients , both men and women , and 32 ( 47,7%) underwent myopia after the capsulotomy procedure with YAG laser and 25 ( 37.3%) hypermetropization and 10 (14.9%) maintained the refraction. The difference in refraction was found by the arithmetic mean of the spherical equivalent for the precapsulotomy procedure of -28.85D and post-capsulotomy of -31.75 D , giving a difference of -2.9 .
It was concluded with this study that the use of posterior capsulotomy with YAG laser post facectomy caused changes in the refraction of the patients studied, presenting myopia with greater frequency in the results. With these data, we observed the need for other future studies with a large number of eyes to prove what happened in this study.
- Conditions
- Refractive and Accommodative Disorders
- Keywords
- YAG laser
What is being measured
The primary outcome is the main question the study is designed to answer.
Refractive changes after capsulotomy with YAG laser
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 posted15 Dec 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive and Accommodative DisordersStudies 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
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Olhos de Goiania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993081
- Sponsor's protocol ID
- ARVO R1 2017
- Acronym
- RCYAG
- Status last verified
- Dec 2016
- First submitted
- 12 Dec 2016
- Last updated
- 15 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REFRACTIVE CHANGES AFTER CAPSULOTOMY WITH YAG LASER
- ClinicalTrials.gov ID
- NCT02993081
- Acronym / sponsor ID
- RCYAG / ARVO R1 2017
- Conditions
- Refractive and Accommodative Disorders
- Keywords
- YAG laser
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Instituto de Olhos de GoianiaUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 15 Dec 2016 (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.
Study of refractive changes after capsulotomy with YAG laser in facectomized patients.
Detailed description
A retrospective, quantitative study was carried out by analyzing the medical records of a reference ophthalmologic hospital in Goiás. Data from the pre and post YAG laser refractive index data were collected from 67 eyes of 66 patients analyzed in the period from May to November 2016.
We studied 67 eyes of 66 patients , both men and women , and 32 ( 47,7%) underwent myopia after the capsulotomy procedure with YAG laser and 25 ( 37.3%) hypermetropization and 10 (14.9%) maintained the refraction. The difference in refraction was found by the arithmetic mean of the spherical equivalent for the precapsulotomy procedure of -28.85D and post-capsulotomy of -31.75 D , giving a difference of -2.9 .
It was concluded with this study that the use of posterior capsulotomy with YAG laser post facectomy caused changes in the refraction of the patients studied, presenting myopia with greater frequency in the results. With these data, we observed the need for other future studies with a large number of eyes to prove what happened in this study.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We studied 67 eyes of 66 patients , both men and women by analyzing the medical records of a reference ophthalmologic hospital in Goiás.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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
Refractive changes after capsulotomy with YAG laser
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 15 Dec 2016.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractive and Accommodative Disorders, run by Instituto de Olhos de Goiania.
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 0 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 15 Dec 2016. 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?
Refractive changes after capsulotomy with YAG laser (time frame: 6 months). 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 15 Dec 2016.