CataractNCT02895074
Subfoveal Choroidal Thickness After Surgery for Age-related Cataracts
A study testing Femtosecond laser-assisted cataract surgery, Conventional phacoemulsification cataract surgery and Tropicamide in people with Cataract, run by Sun Yat-sen University at 1 site in China.
Trial summary
To compare the effects of femtosecond laser-assisted cataract surgery (FLACS) and conventional phacoemulsification surgery (CPS) on subfoveal choroidal thickness (SFCT) in age-related cataracts. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cataract
- What is being tested?
- Femtosecond laser-assisted cataract surgery, Conventional phacoemulsification cataract surgery and Tropicamide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Aug 2014to Jun 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The cataract stages of the patients were between N2 and N4 according to the LOCS III.
Who cannot join
- eyes with histories of ocular surgery, trauma, and ocular diseases, including diabetic retinopathy, age-related macular degeneration (AMD), high myopia, psudoexfoliation, uveitis, retinal vein occlusion, and other inflammatory and vascular retinal disorders.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
Official title: Subfoveal Choroidal Thickness After Femtosecond Laser-assisted Cataract Surgery for Age-related Cataracts
To compare the effects of femtosecond laser-assisted cataract surgery (FLACS) and conventional phacoemulsification surgery (CPS) on subfoveal choroidal thickness (SFCT) in age-related cataracts.
Read the detailed description
It is not clear whether femtosecond laser-assisted cataract surgery (FLACS) alters retinal and choroidal thickness. The goal of the present study was to determine the changes of retinal and choroidal thicknesses in patients who have undergone FLACS compared to patients who have undergone conventional phacoemulsification surgery (CPS).
- Conditions
- Cataract
- Being tested
- Femtosecond laser-assisted cataract surgery, Conventional phacoemulsification cataract surgery, Tropicamide, Proparacaine hydrochloride
- Keywords
- femtosecond laser-assisted cataract surgery (FLACS), subfoveal choroidal thickness (SFCT), conventional phacoemulsification surgery (CPS)
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femtosecond laser-assisted cataract surgeryProcedure or surgery
A femtosecond laser (Alcon-Lensx, Alcon-Lensx, Inc.) was used in this study. After pupil dilation and topical anesthesia, the laser was docked to the eye using a curved contact lens to applanate the cornea. With the integrated OCT imaging system, the locations of the cornea and the anterior and posterior surfaces of the crystalline lens were determined. A 5.0-mm-diameter capsulotomy was created by scanning a cylindrical pattern and followed by lens fragmentation. The laser was disconnected, and the remainder of the surgery was performed as phacoemulsification (Infiniti® Vision System; Alcon, USA). Folded intraocular lenses (IOLs) were implanted in the capsular bags.
Conventional phacoemulsification cataract surgeryProcedure or surgery
Phacoemulsification was performed through a temporal 3.2-mm clear corneal incision with the same machine and followed by IOLs implantation.
TropicamideDrug
After pupil dilation, 1 drop of tropicamide (0.5%) was applied every 15 minutes for 3 applications
Proparacaine hydrochlorideDrug
topical anesthesia with proparacaine hydrochloride (0.5%) was applied.
| Study group | Role | What they receive |
|---|---|---|
| femtosecond laser-assisted cataract surgery group | Experimental | Not described Receives: Procedure: Femtosecond laser-assisted cataract surgery; Drug: Tropicamide; Drug: Proparacaine hydrochloride |
| conventional phacoemulsification surgery group | Experimental | Not described Receives: Procedure: Conventional phacoemulsification cataract surgery; Drug: Tropicamide; Drug: Proparacaine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of subfoveal choroidal thickness
The subfoveal choroidal thickness were measured at baseline and at 1 day, 7 days , 1 month , and 3 months postoperatively by spectral-domain optical coherence tomography.
Measured: baseline, at 1 day after surgery, 7 days after surgery, 1 month after surgery, and 3 months after surgery
Secondary outcomes (1)
The change of subfoveal retinal thickness
The subfoveal retinal thickness were measured at baseline and at 1 day, 7 days , 1 month , and 3 months postoperatively by spectral-domain optical coherence tomography.
Measured: baseline, at 1 day after surgery, 7 days after surgery, 1 month after surgery, and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startAug 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, China
- Responsible party
- Principal investigator, Haotian Lin, Sun Yat-sen University
- Investigators
- Haotian Lin, M.D., Ph.D, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityYizhi Liu, M.D., Ph.D, Study chair, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityWeirong Chen, M.D., Study director, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895074
- Sponsor's protocol ID
- CCPMOH2016-China7
- Status last verified
- Sep 2016
- First submitted
- 29 Aug 2016
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen X, Xiao W, Ye S, Chen W, Liu Y. Efficacy and safety of femtosecond laser-assisted cataract surgery versus conventional phacoemulsification for cataract: a meta-analysis of randomized controlled trials. Sci Rep. 2015 Aug 13;5:13123. doi: 10.1038/srep13123.
PubMed 26269445
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subfoveal Choroidal Thickness After Femtosecond Laser-assisted Cataract Surgery for Age-related Cataracts
- ClinicalTrials.gov ID
- NCT02895074
- Acronym / sponsor ID
- CCPMOH2016-China7
- Conditions
- Cataract
- Keywords
- femtosecond laser-assisted cataract surgery (FLACS), subfoveal choroidal thickness (SFCT), conventional phacoemulsification surgery (CPS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, China
- Study start
- Aug 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 9 Sep 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.
To compare the effects of femtosecond laser-assisted cataract surgery (FLACS) and conventional phacoemulsification surgery (CPS) on subfoveal choroidal thickness (SFCT) in age-related cataracts.
Detailed description
It is not clear whether femtosecond laser-assisted cataract surgery (FLACS) alters retinal and choroidal thickness. The goal of the present study was to determine the changes of retinal and choroidal thicknesses in patients who have undergone FLACS compared to patients who have undergone conventional phacoemulsification surgery (CPS).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| femtosecond laser-assisted cataract surgery group | Experimental | Procedure: Femtosecond laser-assisted cataract surgery, Drug: Tropicamide, Drug: Proparacaine hydrochloride |
| conventional phacoemulsification surgery group | Experimental | Procedure: Conventional phacoemulsification cataract surgery, Drug: Tropicamide, Drug: Proparacaine hydrochloride |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The cataract stages of the patients were between N2 and N4 according to the LOCS III.
Key exclusion criteria (1 listed)
- eyes with histories of ocular surgery, trauma, and ocular diseases, including diabetic retinopathy, age-related macular degeneration (AMD), high myopia, psudoexfoliation, uveitis, retinal vein occlusion, and other inflammatory and vascular retinal disorders.
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 |
|---|---|---|
| Femtosecond laser-assisted cataract surgeryA femtosecond laser (Alcon-Lensx, Alcon-Lensx, Inc.) was used in this study. After pupil dilation and topical anesthesia, the laser was docked to the eye using a curved contact lens to applanate the cornea. With the integrated OCT imaging system, the locations of the cornea and the anterior and posterior surfaces of the crystalline lens were determined. A 5.0-mm-diameter capsulotomy was created by scanning a cylindrical pattern and followed by lens fragmentation. The laser was disconnected, and the remainder of the surgery was performed as phacoemulsification (Infiniti® Vision System; Alcon, USA). Folded intraocular lenses (IOLs) were implanted in the capsular bags. | Procedure or surgery | femtosecond laser-assisted cataract surgery group |
| Conventional phacoemulsification cataract surgeryPhacoemulsification was performed through a temporal 3.2-mm clear corneal incision with the same machine and followed by IOLs implantation. | Procedure or surgery | conventional phacoemulsification surgery group |
| TropicamideAfter pupil dilation, 1 drop of tropicamide (0.5%) was applied every 15 minutes for 3 applications | Drug | conventional phacoemulsification surgery group, femtosecond laser-assisted cataract surgery group |
| Proparacaine hydrochloridetopical anesthesia with proparacaine hydrochloride (0.5%) was applied. | Drug | conventional phacoemulsification surgery group, femtosecond laser-assisted cataract surgery group |
Primary outcome
The change of subfoveal choroidal thickness
Time frame: baseline, at 1 day after surgery, 7 days after surgery, 1 month after surgery, and 3 months after surgery
The subfoveal choroidal thickness were measured at baseline and at 1 day, 7 days , 1 month , and 3 months postoperatively by spectral-domain optical coherence tomography.
1 secondary outcome
The change of subfoveal retinal thickness
Time frame: baseline, at 1 day after surgery, 7 days after surgery, 1 month after surgery, and 3 months after surgery
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 9 Sep 2016.
- Background: PubMed 26269445Chen X, Xiao W, Ye S, Chen W, Liu Y. Efficacy and safety of femtosecond laser-assisted cataract surgery versus conventional phacoemulsification for cataract: a meta-analysis of randomized controlled trials. Sci Rep. 2015 Aug 13;5:13123. doi: 10.1038/srep13123.
- Description Home page of Zhongshan Ophthalmic CenterLink provided by the sponsor.
- Homepage of Childhood Cataract Program of the Chinese Ministry of Health(CCPMOH)Link 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.
Haotian Lin, M.D., Ph.D principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
Yizhi Liu, M.D., Ph.D study chair
Zhongshan Ophthalmic Center, Sun Yat-sen University
Weirong Chen, M.D. study director
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femtosecond laser-assisted cataract surgery, Conventional phacoemulsification cataract surgery and Tropicamide in people with Cataract, run by Sun Yat-sen University 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 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 9 Sep 2016. 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?
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?
The change of subfoveal choroidal thickness (time frame: baseline, at 1 day after surgery, 7 days after surgery, 1 month after surgery, and 3 months after surgery). 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 NCT02895074, which also lists 1 linked publication.
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 9 Sep 2016.