AphakiaNCT06389643
Comparison of Safety and Efficacy of Four-Point Scleral Intraocular Lens Fixation and Yamane Techniques
A study testing Four-point scleral fixation of Akreos AO60 IOL and Sutureless scleral fixation of AcrySof MA60AC IOL with Yamane technique in people with Aphakia, run by Military Institute od Medicine National Research Institute at 1 site in Poland.
Trial summary
Comparison of safety and efficacy of two scleral fixation intraocular lens (IOL) methods of four-point scleral fixation ( Akreos AO60) and the Yamane technique (AcrySof MA60AC) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aphakia
- What is being tested?
- Four-point scleral fixation of Akreos AO60 IOL and Sutureless scleral fixation of AcrySof MA60AC IOL with Yamane technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 19 Mar 2021to 19 Sep 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- only adult men and women with aphakia without capsular support
Who cannot join
- Fuchs' dystrophy
- corneal haze or scarring
- history of corneal transplantation
- astigmatism of more than 2,0D
- clinically active uveitis
- advanced glaucoma
- macular diseases that affect visual acuity (age-related macular degeneration, diabetic maculopathy)
Trial locations and contacts
1 site in 1 country.
Poland1 site
Military Institute of Medicine - National Research Institute
Warsaw, 04-141
About this study
Comparison of safety and efficacy of two scleral fixation intraocular lens (IOL) methods of four-point scleral fixation ( Akreos AO60) and the Yamane technique (AcrySof MA60AC)
Read the detailed description
Purpose of the study is to compare two methods of scleral fixation of IOL: two-point fixation of AcrySof MA60AC IOL (Alcon) using Yamane technique and four-point fixation of the Akreos AO60 IOL (Bausch \& Lomb) using polypropylene suture. The investigators rated the BCVA, refractive outcomes, intraocular pressure, and also determined intra- and postoperative complications.
- Conditions
- Aphakia
- Being tested
- Four-point scleral fixation of Akreos AO60 IOL, Sutureless scleral fixation of AcrySof MA60AC IOL with Yamane technique
- Keywords
- scleral fixation IOL, sutureless fixation IOL, four-point scleral fixation, Yamane technique, aphakia
- Medical subject headings
- Aphakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Four-point scleral fixation of Akreos AO60 IOLProcedure or surgery
Intrascleral tunnels were marked at a distance of 2 mm from the corneal limbus, 6 mm apart (4 in number) after retrobulbar anesthesia. Next corneal incisions were performed. An artificial lens was then implanted into the anterior chamber. The 6-0 polypropylene suture was introduced into the anterior chamber through openings in the cornea. The next stage was to perform a sclerotomy using a 30G needle. Then the needle was passed through the hole in the haptic and 6-0 polypropylene suture was inserted into the needle hole and guided outside. The other end of the suture, passed through the opening in the haptic, was placed in the lumen of the needle and carried out through another sclerotomy and then externalised. This maneuver was repeated with another haptics as well. Correct position of the IOL in the eye was achieved by pulling on the ends of the monofilament. The ends of sutures were trimmed and cauterized. The melted tips of the sutures were then fixed subconjunctivally.
Sutureless scleral fixation of AcrySof MA60AC IOL with Yamane techniqueProcedure or surgery
The surgery was performed under retrobulbar anesthesia. The first step of the procedure was to mark the locations of the intrascleral tunnels (2 mm from the corneal limbus) and locate them at a distance of 180° from each other to prevent the lens from tilting in the eyeball. Openings in the cornea were done. Three-piece IOL was implanted into the anterior chamber. The first sclerotomy was performed through the conjunctiva using a 30G needle 2 mm from the limbus. One of the haptics was inserted into the needle lumen and then brought out. Same procedure was performed with another haptic at a distance of 180°. The next step was to perform cautery of the tips of the haptics, obtaining a 0.3 mm collar that prevents the risk of the haptic coming out of the tunnel and displacing the lens inside the eyeball. The tips of the haptics were finally gently inserted into the scleral canals and covered with conjunctiva.
| Study group | Role | What they receive |
|---|---|---|
| Four-point scleral fixation group | Active comparator | Four-point scleral fixation group Receives: Procedure: Four-point scleral fixation of Akreos AO60 IOL |
| Yamane technique group | Active comparator | Yamane technique group Receives: Procedure: Sutureless scleral fixation of AcrySof MA60AC IOL with Yamane technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
BCVA
The change of best- corrected visual acuity
Measured: before and 12 months after surgery
RE
Postoperative total refractive error
Measured: 12 months after surgery
ECC
corneal endothelial cell density
Measured: before and 12 months after surgery
Secondary outcomes (1)
Number of complications
Rate of complications
Measured: from day 1 until 12 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 posted29 Apr 2024
- Study start19 Mar 2021
- Primary completion14 Sep 2022
- Study completion19 Sep 2023
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 AphakiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Military Institute od Medicine National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natalia Blagun, MD, Principal investigator, Military Institute od Medicine National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389643
- Sponsor's protocol ID
- 11/WIM/2021
- Status last verified
- Apr 2024
- First submitted
- 17 Apr 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blagun N, Krix-Jachym K, Rekas M. Comparison of Safety and Efficacy of Four-Point Scleral Intraocular Lens Fixation and the Yamane Technique. Ophthalmol Ther. 2024 Jul;13(7):1955-1966. doi: 10.1007/s40123-024-00962-7. Epub 2024 May 21.
PubMed 38771460
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Safety and Efficacy of Four-Point Scleral Intraocular Lens Fixation and Yamane Techniques
- ClinicalTrials.gov ID
- NCT06389643
- Acronym / sponsor ID
- 11/WIM/2021
- Conditions
- Aphakia
- Keywords
- scleral fixation IOL, sutureless fixation IOL, four-point scleral fixation, Yamane technique, aphakia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Military Institute od Medicine National Research InstituteUniversity, hospital or other
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 14 Sep 2022 (actual)
- Study completion
- 19 Sep 2023 (actual)
- First posted
- 29 Apr 2024 (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.
Comparison of safety and efficacy of two scleral fixation intraocular lens (IOL) methods of four-point scleral fixation ( Akreos AO60) and the Yamane technique (AcrySof MA60AC)
Detailed description
Purpose of the study is to compare two methods of scleral fixation of IOL: two-point fixation of AcrySof MA60AC IOL (Alcon) using Yamane technique and four-point fixation of the Akreos AO60 IOL (Bausch \& Lomb) using polypropylene suture. The investigators rated the BCVA, refractive outcomes, intraocular pressure, and also determined intra- and postoperative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Four-point scleral fixation group | Active comparator | Procedure: Four-point scleral fixation of Akreos AO60 IOLFour-point scleral fixation group |
| Yamane technique group | Active comparator | Procedure: Sutureless scleral fixation of AcrySof MA60AC IOL with Yamane techniqueYamane technique group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- only adult men and women with aphakia without capsular support
Key exclusion criteria (7 listed)
- Fuchs' dystrophy
- corneal haze or scarring
- history of corneal transplantation
- astigmatism of more than 2,0D
- clinically active uveitis
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 |
|---|---|---|
| Four-point scleral fixation of Akreos AO60 IOLIntrascleral tunnels were marked at a distance of 2 mm from the corneal limbus, 6 mm apart (4 in number) after retrobulbar anesthesia. Next corneal incisions were performed. An artificial lens was then implanted into the anterior chamber. The 6-0 polypropylene suture was introduced into the anterior chamber through openings in the cornea. The next stage was to perform a sclerotomy using a 30G needle. Then the needle was passed through the hole in the haptic and 6-0 polypropylene suture was inserted into the needle hole and guided outside. The other end of the suture, passed through the opening in the haptic, was placed in the lumen of the needle and carried out through another sclerotomy and then externalised. This maneuver was repeated with another haptics as well. Correct position of the IOL in the eye was achieved by pulling on the ends of the monofilament. The ends of sutures were trimmed and cauterized. The melted tips of the sutures were then fixed subconjunctivally. | Procedure or surgery | Four-point scleral fixation group |
| Sutureless scleral fixation of AcrySof MA60AC IOL with Yamane techniqueThe surgery was performed under retrobulbar anesthesia. The first step of the procedure was to mark the locations of the intrascleral tunnels (2 mm from the corneal limbus) and locate them at a distance of 180° from each other to prevent the lens from tilting in the eyeball. Openings in the cornea were done. Three-piece IOL was implanted into the anterior chamber. The first sclerotomy was performed through the conjunctiva using a 30G needle 2 mm from the limbus. One of the haptics was inserted into the needle lumen and then brought out. Same procedure was performed with another haptic at a distance of 180°. The next step was to perform cautery of the tips of the haptics, obtaining a 0.3 mm collar that prevents the risk of the haptic coming out of the tunnel and displacing the lens inside the eyeball. The tips of the haptics were finally gently inserted into the scleral canals and covered with conjunctiva. | Procedure or surgery | Yamane technique group |
Primary outcome
BCVA
Time frame: before and 12 months after surgery
The change of best- corrected visual acuity
RE
Time frame: 12 months after surgery
Postoperative total refractive error
ECC
Time frame: before and 12 months after surgery
corneal endothelial cell density
1 secondary outcome
Number of complications
Time frame: from day 1 until 12 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 29 Apr 2024.
- Derived from this study: PubMed 38771460Blagun N, Krix-Jachym K, Rekas M. Comparison of Safety and Efficacy of Four-Point Scleral Intraocular Lens Fixation and the Yamane Technique. Ophthalmol Ther. 2024 Jul;13(7):1955-1966. doi: 10.1007/s40123-024-00962-7. Epub 2024 May 21.
- 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.
Natalia Blagun, MD principal investigator
Military Institute od Medicine National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Four-point scleral fixation of Akreos AO60 IOL and Sutureless scleral fixation of AcrySof MA60AC IOL with Yamane technique in people with Aphakia, run by Military Institute od Medicine National Research Institute at 1 site in Poland.
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 7 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 29 Apr 2024. 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 Poland. 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?
BCVA (time frame: before and 12 months after surgery). The study lists 3 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 NCT06389643, 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 29 Apr 2024.