Congenital Ectopia LentisNCT07446829
Effect of Different Needle Insertion Positions on the Clinical Outcomes of YAMANE Technique
A study testing YAMANE technique(Suture Needle Insertion at 2.5 mm Posterior to the Limbus) in people with Congenital Ectopia Lentis, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
This is a single-blind, single-center, parallel-group randomized controlled trial with the following objectives: First, researchers aim to compare the clinical efficacy of 2mm and 2.5mm post-limbal needle insertion in YAMANE technique for patients with congenital ectopia lentis. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Congenital Ectopia Lentis
- What is being tested?
- YAMANE technique(Suture Needle Insertion at 2.5 mm Posterior to the Limbus)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2026to 30 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged 4-18 years (regardless of gender) who meet the indications for YAMANE technique.
- Patients who can complete a follow-up period of at least 3 months after surgery.
- Patients or their legal guardians who provide informed consent to participate in this study.
Who cannot join
- Patients with concurent secondary qlaucoma, retinal detachment, strabismus, or other relevant ocular complications (excluding refractive errors).
- Patients participating in other trials that may affect the results of this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Clinical Research Center for Ocular Diseases, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science
Guangdong, Province, 510060
Guangming Jin, +86 13560035613, jinguangming@gzzoc.com
About this study
Official title: Effect of Different Needle Insertion Positions on the Clinical Outcomes of YAMANE Technique for Intrascleral Intraocular Lens Fixation: a Randomized Controlled Trial
This is a single-blind, single-center, parallel-group randomized controlled trial with the following objectives: First, researchers aim to compare the clinical efficacy of 2mm and 2.5mm post-limbal needle insertion in YAMANE technique for patients with congenital ectopia lentis. Second, the goal is to investigate the mean absolute refractive prediction error, IOL tilt and decentration, uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA), and corneal endothelial cell count at 3 months postoperatively. Third, it intends to explore the incidence of postoperative complications of the two needle insertion positions in this specific surgical method. Finally, this study aims to provide evidence for ophthalmic clinical practice, explore the optimal needle insertion point, and offer more precise and safe surgical plans for patients requiring sutureless transscleral IOL fixation.
Read the detailed description
For patients with insufficient capsular bag support caused by congenital developmental abnormalities, trauma, or other etiologies and who meet the indications for intraocular lens (IOL) implantation, IOL suspension surgery is the primary surgical procedure. As an innovative IOL suspension technique, the YAMANE technique has been widely favored by ophthalmologists. Due to its sutureless feature, this technique reduces the risk of postoperative complications such as infection and hypotony, while greatly simplifying surgical procedures.
In previous studies on the YAMANE technique, needle insertion sites were commonly set at 2 mm and 2.5 mm posterior to the cornea limbus. Among them, the 2.5 mm post-limbal insertion point was associated with a smaller mean absolute refractive prediction error and better clinical outcomes. Although a few studies have evaluated the clinical efficacy of the YAMANE technique, no study has systematically compared its clinical outcomes between different needle insertion positions. Considering that differences in the insertion point may directly affect postoperative refractive status, IOL stability, and visual outcomes, evaluating the impact of different insertion sites on surgical results is critical for optimizing surgical strategies and improving therapeutic efficacy.
In this randomized controlled trial, the investigators will systematically investigate the clinical efficacy of needle insertion at 2 mm versus 2.5 mm posterior to the cornea limbus in the YAMANE technique. Through this study, the investigators aim to provide evidence for ophthalmic clinical practice, explore the optimal needle insertion point, and offer a more precise and safe surgical plan for patients undergoing the YAMANE technique.
- Conditions
- Congenital Ectopia Lentis
- Being tested
- YAMANE technique(Suture Needle Insertion at 2.5 mm Posterior to the Limbus)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YAMANE technique(Suture Needle Insertion at 2.5 mm Posterior to the Limbus)Procedure or surgery
Participants in the intervention group should complete a comprehensive ophthalmic examination at baseline, undergo needle insertion 2.5mm post-limbal during surgery, and receive routine follow-up at 1 week, 1 month, and 3 months postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| intervention group(suture needle insertion at 2.5 mm posterior to the cornea limbus) | Experimental | Participants in the intervention group should complete a comprehensive ophthalmic examination at baseline, undergo needle insertion 2.5mm post-limbal during surgery,and receive routine follow-up at 1 week, 1 month, and 3 months postoperatively. Receives: Procedure: YAMANE technique(Suture Needle Insertion at 2.5 mm Posterior to the Limbus) |
| compare group(suture needle insertion at 2 mm posterior to the cornea limbus) | No intervention | Participants in the intervention group should complete a comprehensive ophthalmic examination at baseline, undergo needle insertion 2mm post-limbal during surgery,and receive routine follow-up at 1 week, 1 month, and 3 months postoperatively |
What is being measured
The primary outcome is the main question the study is designed to answer.
Refractive Predictive Error of Patients at the 3-month Postoperative Follow-up
Case report form records
Measured: 3-month Postoperative Follow-up
Secondary outcomes (6)
Uncorrected Visual Acuity (UCVA) of Patients at the 3-Month Postoperative Follow-up
Measured using the EDTRS chart
Measured: 3-month Postoperative Follow-up
Best-Corrected Visual Acuity (BCVA) of Patients at the 3-Month Postoperative Follow-up
Measured using the EDTRS chart
Measured: 3-month Postoperative Follow-up
IOL Tilt in Patients at the 3-Month Postoperative Follow-up
by the Casia 2 AS-OCT Instrument
Measured: 3-month Postoperative Follow-up
IOL Decentration in Patients at the 3-Month Postoperative Follow-up
by the Casia 2 AS-OCT Instrument
Measured: 3-month Postoperative Follow-up
Corneal Endothelial Cell Count of Patients at the 3-Month Postoperative Follow-up
Measured using a corneal endothelial microscope
Measured: 3-month Postoperative Follow-up
Incidence of Postoperative Complications at the 3-Month Postoperative Follow-up
Measured: 3-month Postoperative Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start28 Feb 2026 (estimated)
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Congenital Ectopia LentisStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guangming Jin, Zhongshan Ophthalmic Center, Sun Yat-sen University
- Investigators
- Danying Zheng, Study chair, Guangdong Provincial Clinical ResearchCenter for Ocular Diseases, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science,Guangzhou, GuangdongGuangming Jin, Principal investigator, Guangdong Provincial Clinical Research Center for Ocular Diseases, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science,Guangzhou, Guangdong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446829
- Sponsor's protocol ID
- 2025KYPJ137
- Status last verified
- Mar 2026
- First submitted
- 25 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Qu Y, Duan P, Huo S, Li F, Li J. Sutured Intrascleral Posterior Chamber Intraocular Lens Fixation with Ciliary Sulcus Location Guided by Ultrasonic Biological Microscopy: A Retrospective Analysis of Anatomical and Refractive Outcome. J Ophthalmol. 2020 Jun 4;2020:5843410. doi: 10.1155/2020/5843410. eCollection 2020.
PubMed 32587761Rocke JR, McGuinness MB, Atkins WK, Fry LE, Kane JX, Fabinyi DCA, Yeoh J, Chiu D, Essex MBiostat RW, Roufail E, Sheridan AM, Allen PJ, Edwards TL. Refractive Outcomes of the Yamane Flanged Intrascleral Haptic Fixation Technique. Ophthalmology. 2020 Oct;127(10):1429-1431. doi: 10.1016/j.ophtha.2020.03.032. Epub 2020 Apr 3. No abstract available.
PubMed 32359838Blagun 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 38771460Trivedi V, Lee S, Lee PSY, Me R, You Q, Im J, Ross B, Tran DV, Le KH, Malbin B, Lin X. Comparative Analysis of Effective Lens Position and Refractive Outcomes in Scleral-Fixated versus Intracapsular Intraocular Lenses. Clin Ophthalmol. 2024 Dec 25;18:3949-3955. doi: 10.2147/OPTH.S486044. eCollection 2024.
PubMed 39737363Erakgun T, Gobeka HH. The novel haptic-twist method for a sutureless double-needle intrascleral haptic fixation technique. Int Ophthalmol. 2021 Sep;41(9):3013-3020. doi: 10.1007/s10792-021-01862-6. Epub 2021 May 20.
PubMed 34014460Schranz M, Reumuller A, Kostolna K, Novotny C, Schartmuller D, Abela-Formanek C. Refractive outcome and lens power calculation after intrascleral intraocular lens fixation: a comparison of three-piece and one-piece intrascleral fixation technique. Eye Vis (Lond). 2023 Jun 9;10(1):29. doi: 10.1186/s40662-023-00341-6.
PubMed 37291668Limon U, Akcay BIS. A novel Yamane technique modification: Reverse intraocular lens implantation for simplifying trailing haptic insertion. Indian J Ophthalmol. 2023 May;71(5):2244-2246. doi: 10.4103/IJO.IJO_3158_22.
PubMed 37202960Sahin Vural G, Guven YZ, Karahan E, Zengin MO. Long term outcomes of Yamane technique in various indications. Eur J Ophthalmol. 2023 Nov;33(6):2210-2216. doi: 10.1177/11206721231167198. Epub 2023 Apr 10.
PubMed 37038337Shasha R. Yamane intrascleral haptic fixation, white-to-white distance, and the temporal approach. J Cataract Refract Surg. 2023 May 1;49(5):543-544. doi: 10.1097/j.jcrs.0000000000001172. No abstract available.
PubMed 37088937Tang Y, Gao Y, Chu Y, Liu Y, Han Q. Modified Yamane technique with a 26-gauge needle: single corneal incision and simplified haptic insertion. J Cataract Refract Surg. 2022 Jan 1;48(1):e1-e4. doi: 10.1097/j.jcrs.0000000000000816.
PubMed 34524208
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Needle Insertion Positions on the Clinical Outcomes of YAMANE Technique for Intrascleral Intraocular Lens Fixation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07446829
- Acronym / sponsor ID
- 2025KYPJ137
- Conditions
- Congenital Ectopia Lentis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 28 Feb 2026 (estimated)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 3 Mar 2026 (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.
This is a single-blind, single-center, parallel-group randomized controlled trial with the following objectives: First, researchers aim to compare the clinical efficacy of 2mm and 2.5mm post-limbal needle insertion in YAMANE technique for patients with congenital ectopia lentis. Second, the goal is to investigate the mean absolute refractive prediction error, IOL tilt and decentration, uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA), and corneal endothelial cell count at 3 months postoperatively. Third, it intends to explore the incidence of postoperative complications of the two needle insertion positions in this specific surgical method. Finally, this study aims to provide evidence for ophthalmic clinical practice, explore the optimal needle insertion point, and offer more precise and safe surgical plans for patients requiring sutureless transscleral IOL fixation.
Detailed description
For patients with insufficient capsular bag support caused by congenital developmental abnormalities, trauma, or other etiologies and who meet the indications for intraocular lens (IOL) implantation, IOL suspension surgery is the primary surgical procedure. As an innovative IOL suspension technique, the YAMANE technique has been widely favored by ophthalmologists. Due to its sutureless feature, this technique reduces the risk of postoperative complications such as infection and hypotony, while greatly simplifying surgical procedures.
In previous studies on the YAMANE technique, needle insertion sites were commonly set at 2 mm and 2.5 mm posterior to the cornea limbus. Among them, the 2.5 mm post-limbal insertion point was associated with a smaller mean absolute refractive prediction error and better clinical outcomes. Although a few studies have evaluated the clinical efficacy of the YAMANE technique, no study has systematically compared its clinical outcomes between different needle insertion positions. Considering that differences in the insertion point may directly affect postoperative refractive status, IOL stability, and visual outcomes, evaluating the impact of different insertion sites on surgical results is critical for optimizing surgical strategies and improving therapeutic efficacy.
In this randomized controlled trial, the investigators will systematically investigate the clinical efficacy of needle insertion at 2 mm versus 2.5 mm posterior to the cornea limbus in the YAMANE technique. Through this study, the investigators aim to provide evidence for ophthalmic clinical practice, explore the optimal needle insertion point, and offer a more precise and safe surgical plan for patients undergoing the YAMANE technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group(suture needle insertion at 2.5 mm posterior to the cornea limbus) | Experimental | Procedure: YAMANE technique(Suture Needle Insertion at 2.5 mm Posterior to the Limbus)Participants in the intervention group should complete a comprehensive ophthalmic examination at baseline, undergo needle insertion 2.5mm post-limbal during surgery,and receive routine follow-up at 1 week, 1 month, and 3 months postoperatively. |
| compare group(suture needle insertion at 2 mm posterior to the cornea limbus) | No intervention | –Participants in the intervention group should complete a comprehensive ophthalmic examination at baseline, undergo needle insertion 2mm post-limbal during surgery,and receive routine follow-up at 1 week, 1 month, and 3 months postoperatively |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients aged 4-18 years (regardless of gender) who meet the indications for YAMANE technique.
- Patients who can complete a follow-up period of at least 3 months after surgery.
- Patients or their legal guardians who provide informed consent to participate in this study.
Key exclusion criteria (2 listed)
- Patients with concurent secondary qlaucoma, retinal detachment, strabismus, or other relevant ocular complications (excluding refractive errors).
- Patients participating in other trials that may affect the results of this study.
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 |
|---|---|---|
| YAMANE technique(Suture Needle Insertion at 2.5 mm Posterior to the Limbus)Participants in the intervention group should complete a comprehensive ophthalmic examination at baseline, undergo needle insertion 2.5mm post-limbal during surgery, and receive routine follow-up at 1 week, 1 month, and 3 months postoperatively. | Procedure or surgery | intervention group(suture needle insertion at 2.5 mm posterior to the cornea limbus) |
Primary outcome
Refractive Predictive Error of Patients at the 3-month Postoperative Follow-up
Time frame: 3-month Postoperative Follow-up
Case report form records
6 secondary outcomes
Uncorrected Visual Acuity (UCVA) of Patients at the 3-Month Postoperative Follow-up
Time frame: 3-month Postoperative Follow-up
Best-Corrected Visual Acuity (BCVA) of Patients at the 3-Month Postoperative Follow-up
Time frame: 3-month Postoperative Follow-up
IOL Tilt in Patients at the 3-Month Postoperative Follow-up
Time frame: 3-month Postoperative Follow-up
IOL Decentration in Patients at the 3-Month Postoperative Follow-up
Time frame: 3-month Postoperative Follow-up
Corneal Endothelial Cell Count of Patients at the 3-Month Postoperative Follow-up
Time frame: 3-month Postoperative Follow-up
Incidence of Postoperative Complications at the 3-Month Postoperative Follow-up
Time frame: 3-month Postoperative Follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Results publication: PubMed 32587761Qu Y, Duan P, Huo S, Li F, Li J. Sutured Intrascleral Posterior Chamber Intraocular Lens Fixation with Ciliary Sulcus Location Guided by Ultrasonic Biological Microscopy: A Retrospective Analysis of Anatomical and Refractive Outcome. J Ophthalmol. 2020 Jun 4;2020:5843410. doi: 10.1155/2020/5843410. eCollection 2020.
- Results publication: PubMed 32359838Rocke JR, McGuinness MB, Atkins WK, Fry LE, Kane JX, Fabinyi DCA, Yeoh J, Chiu D, Essex MBiostat RW, Roufail E, Sheridan AM, Allen PJ, Edwards TL. Refractive Outcomes of the Yamane Flanged Intrascleral Haptic Fixation Technique. Ophthalmology. 2020 Oct;127(10):1429-1431. doi: 10.1016/j.ophtha.2020.03.032. Epub 2020 Apr 3. No abstract available.
- Results publication: 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.
- Results publication: PubMed 39737363Trivedi V, Lee S, Lee PSY, Me R, You Q, Im J, Ross B, Tran DV, Le KH, Malbin B, Lin X. Comparative Analysis of Effective Lens Position and Refractive Outcomes in Scleral-Fixated versus Intracapsular Intraocular Lenses. Clin Ophthalmol. 2024 Dec 25;18:3949-3955. doi: 10.2147/OPTH.S486044. eCollection 2024.
- Results publication: PubMed 34014460Erakgun T, Gobeka HH. The novel haptic-twist method for a sutureless double-needle intrascleral haptic fixation technique. Int Ophthalmol. 2021 Sep;41(9):3013-3020. doi: 10.1007/s10792-021-01862-6. Epub 2021 May 20.
- Results publication: PubMed 37291668Schranz M, Reumuller A, Kostolna K, Novotny C, Schartmuller D, Abela-Formanek C. Refractive outcome and lens power calculation after intrascleral intraocular lens fixation: a comparison of three-piece and one-piece intrascleral fixation technique. Eye Vis (Lond). 2023 Jun 9;10(1):29. doi: 10.1186/s40662-023-00341-6.
- Results publication: PubMed 37202960Limon U, Akcay BIS. A novel Yamane technique modification: Reverse intraocular lens implantation for simplifying trailing haptic insertion. Indian J Ophthalmol. 2023 May;71(5):2244-2246. doi: 10.4103/IJO.IJO_3158_22.
- Results publication: PubMed 37038337Sahin Vural G, Guven YZ, Karahan E, Zengin MO. Long term outcomes of Yamane technique in various indications. Eur J Ophthalmol. 2023 Nov;33(6):2210-2216. doi: 10.1177/11206721231167198. Epub 2023 Apr 10.
- Results publication: PubMed 37088937Shasha R. Yamane intrascleral haptic fixation, white-to-white distance, and the temporal approach. J Cataract Refract Surg. 2023 May 1;49(5):543-544. doi: 10.1097/j.jcrs.0000000000001172. No abstract available.
- Results publication: PubMed 34524208Tang Y, Gao Y, Chu Y, Liu Y, Han Q. Modified Yamane technique with a 26-gauge needle: single corneal incision and simplified haptic insertion. J Cataract Refract Surg. 2022 Jan 1;48(1):e1-e4. doi: 10.1097/j.jcrs.0000000000000816.
- Individual participant dataSharing planned: Yes
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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.
Danying Zheng study chair
Guangdong Provincial Clinical ResearchCenter for Ocular Diseases, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science,Guangzhou, Guangdong
Guangming Jin principal investigator
Guangdong Provincial Clinical Research Center for Ocular Diseases, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science,Guangzhou, Guangdong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing YAMANE technique(Suture Needle Insertion at 2.5 mm Posterior to the Limbus) in people with Congenital Ectopia Lentis, run by Zhongshan Ophthalmic Center, 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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 4 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guangming Jin (+86 13560035613, jinguangming@gzzoc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Refractive Predictive Error of Patients at the 3-month Postoperative Follow-up (time frame: 3-month Postoperative Follow-up). 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 NCT07446829, which also lists 10 linked publications.
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 4 Mar 2026.