SubluxationNCT06773273
A Novel Approach to Lens Subluxation
A study testing CapsuLaser-Assisted Capsulorhexis and Flanged Prolene Suture in people with Subluxation, run by Zagazig University at 1 site in Saudi Arabia.
Trial summary
Evaluating new technique for treating patients with subluxation using specific laser type and new 6-0 proline fixating novel technique for the capsular bag Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Subluxation
- What is being tested?
- CapsuLaser-Assisted Capsulorhexis and Flanged Prolene Suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 28 May 2024to 1 Dec 2024
- 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
- Lens subluxation with clear corneal media.
Who cannot join
- Associated macular lesions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel Approach to Lens Subluxation: CapsuLaser and Flanged Prolene Suture for Cionni Ring Scleral Fixation
Evaluating new technique for treating patients with subluxation using specific laser type and new 6-0 proline fixating novel technique for the capsular bag
Read the detailed description
The management of a subluxated crystalline lens remains a challenge for anterior segment surgeons, largely due to the complex anatomical and functional changes in such cases. Capsulaser is safe and effective tool in creating well centered CCC with consistent 360 degree IOL coverage that ensures better lens stability and effective lens positioning . Combined with using flanged 6-0 Prolene sutures for scleral fixation of Cionni rings, this technique addresses previous limitations by improving intraoperative control.
- Conditions
- Subluxation
- Being tested
- CapsuLaser-Assisted Capsulorhexis and Flanged Prolene Suture
- Keywords
- Subluxation, CapsuLaser, Prolene, Cionni
- Medical subject headings
- Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapsuLaser-Assisted Capsulorhexis and Flanged Prolene SutureProcedure or surgery
CapsuLaser-Assisted Capsulorhexis and Flanged 6-0 Prolene Suture for Cionni Ring Scleral Fixation
| Study group | Role | What they receive |
|---|---|---|
| CapsuLaser-Assisted Capsulorhexis and Flanged Prolene Suture | Other | CapsuLaser-Assisted Capsulorhexis and Flanged 6-0 Prolene Suture for Cionni Ring Scleral Fixation Receives: Procedure: CapsuLaser-Assisted Capsulorhexis and Flanged Prolene Suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cases with IOL centration inside the capsular bag
the long term stability of the capsular bag
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 posted14 Jan 2025
- Study start28 May 2024
- Primary completion1 Oct 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SubluxationStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Not applicable
- Intervention model
- Single group
- Model description
- This retrospective interventional randomized study included 15 eyes of 15 patients; six of them were due to pseudo exfoliation, five of them were males while the other nine cases were due to hereditary lens subluxation eight of them were females.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- AHMED SAMIR, MD,PhD, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773273
- Sponsor's protocol ID
- MEH-IRB# 355 -5-January -2025
- Other IDs
- Maghrabi eye hospitals
- Status last verified
- Jan 2025
- First submitted
- 29 Dec 2024
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Approach to Lens Subluxation: CapsuLaser and Flanged Prolene Suture for Cionni Ring Scleral Fixation
- ClinicalTrials.gov ID
- NCT06773273
- Acronym / sponsor ID
- MEH-IRB# 355 -5-January -2025
- Conditions
- Subluxation
- Keywords
- Subluxation, CapsuLaser, Prolene, Cionni
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 28 May 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 14 Jan 2025 (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.
Evaluating new technique for treating patients with subluxation using specific laser type and new 6-0 proline fixating novel technique for the capsular bag
Detailed description
The management of a subluxated crystalline lens remains a challenge for anterior segment surgeons, largely due to the complex anatomical and functional changes in such cases. Capsulaser is safe and effective tool in creating well centered CCC with consistent 360 degree IOL coverage that ensures better lens stability and effective lens positioning . Combined with using flanged 6-0 Prolene sutures for scleral fixation of Cionni rings, this technique addresses previous limitations by improving intraoperative control.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This retrospective interventional randomized study included 15 eyes of 15 patients; six of them were due to pseudo exfoliation, five of them were males while the other nine cases were due to hereditary lens subluxation eight of them were females.
| Arm | Type | Receives |
|---|---|---|
| CapsuLaser-Assisted Capsulorhexis and Flanged Prolene Suture | Other | Procedure: CapsuLaser-Assisted Capsulorhexis and Flanged Prolene SutureCapsuLaser-Assisted Capsulorhexis and Flanged 6-0 Prolene Suture for Cionni Ring Scleral Fixation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Lens subluxation with clear corneal media.
Key exclusion criteria (1 listed)
- Associated macular lesions.
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 |
|---|---|---|
| CapsuLaser-Assisted Capsulorhexis and Flanged Prolene SutureCapsuLaser-Assisted Capsulorhexis and Flanged 6-0 Prolene Suture for Cionni Ring Scleral Fixation | Procedure or surgery | CapsuLaser-Assisted Capsulorhexis and Flanged Prolene Suture |
Primary outcome
Number of cases with IOL centration inside the capsular bag
Time frame: 6 months
the long term stability of the capsular bag
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 14 Jan 2025.
- Individual participant dataSharing planned: No
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Investigation of the Relationship Between Shoulder Alpha Angle and Humeral Head Displacement Percentage Measured by Ultrasonography in Neonatal Brachial Plexus Palsy Infants With Clinical Parameters
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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.
AHMED SAMIR, MD,PhD principal investigator
Zagazig 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 CapsuLaser-Assisted Capsulorhexis and Flanged Prolene Suture in people with Subluxation, run by Zagazig University at 1 site in Saudi Arabia.
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 14 Jan 2025. 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 Saudi Arabia. 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?
Number of cases with IOL centration inside the capsular bag (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 14 Jan 2025.