Age-related CataractNCT07550907
The Impact of Surgical Procedures on Postoperative Outcomes in Cataract Phacoemulsification and Analysis of Related Factors
An observational study of Age-related Cataract, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
The goal of this observational study is to evaluate the location of phacoemulsification tip measured by intraoperative OCT during cataract surgeries and its impact on early postoperative changes of cornea and visual acuity. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Age-related Cataract
- What is being tested?
- cataract surgery
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2026to 30 Jun 2027
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are planning to receive phacoemulsification combined with intraocular lens implantation for unilateral/bilateral age-related cataract
Who may be able to join
- Age ≥ 50 years and ≤ 90 years
- Diagnosis of unilateral/bilateral age-related cataract
- Nuclear grade ≥2 in LOCSIII classification
- Scheduled for cataract phacoemulsification combined with intraocular lens implantation
- Pupil size ≥6mm after dilation
- Corneal endothelial cell count ≥1500 cells/mm²
Who cannot join
- Diagnosis of severe systemic disease (e.g., severe hypertension or Alzheimer's disease)
- History of ocular trauma or surgery
- Presence of other ocular diseases (such as glaucoma, diabetic retinopathy, or high myopia)
- Other ocular factors that may complicate the surgery (such as small pupil, shallow anterior chamber)
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, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Zitian Liu, MD, PhD, +8618319249014, liuzt25@mail.sysu.edu.cn
About this study
The goal of this observational study is to evaluate the location of phacoemulsification tip measured by intraoperative OCT during cataract surgeries and its impact on early postoperative changes of cornea and visual acuity. The main question it aims to answer is:
In patients with age-related cataracts undergoing phacoemulsification, does the location (supracapsular, iris-lens diaphragm, or endocapsular) of the phaco tip affect postoperative corneal changes and visual acuity at early postoperative stage? Eyes having phacoemulsification for cataracts will receive intraoperative OCT imaging to evaluate the location of the phaco tip during surgery, and corneal changes and visual acuity will be measured postoperatively.
- Conditions
- Age-related Cataract
- Being tested
- cataract surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cataract surgeryProcedure or surgery
Cataract phacoemulsification combined with intraocular lens implantation
| Study group | Role | What they receive |
|---|---|---|
| Phacoemulsification | Not described Receives: Procedure: cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in corneal thickness
Corneal thickness measured by corneal endothelial specular microscope
Measured: postoperative day 1, week 1, and month 1
Secondary outcomes (3)
Change in corneal endothelial cell density
Measured using corneal endothelial specular microscope
Measured: 1 day, 1 week, and 1 month postoperatively
Best-corrected visual acuity
Measured using ETDRS visual acuity protocol with ETDRS visual acuity chart by a masked examiner
Measured: 1 day, 1 week, and 1 month postoperatively
Intraoperative and postoperative complications
Monitored by cataract surgeons using intraoperative OCT and postoperative slit-lamp examination. Complications include Descemet membrane detachment, posterior capsule rupture, incision leakage, and etc.
Measured: Intraoperative, 1 day, 1 week, and 1 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start20 Apr 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Age-related CataractStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zitian Liu, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550907
- Sponsor's protocol ID
- IIT2025172
- Status last verified
- Jun 2026
- First submitted
- 15 Apr 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu Z, Lin H, Jin L, Qu B, Liu J, Zheng Y, He M, Luo L, Liu Y. Swab Pressing vs Stromal Hydration to Prevent Incision Leakage and Transient Collapse of Anterior Chamber in Phacoemulsification: A Randomized Clinical Trial. JAMA Ophthalmol. 2023 Jun 1;141(6):574-581. doi: 10.1001/jamaophthalmol.2023.1491.
PubMed 37166786Liu Y, Zeng M, Liu X, Luo L, Yuan Z, Xia Y, Zeng Y. Torsional mode versus conventional ultrasound mode phacoemulsification: randomized comparative clinical study. J Cataract Refract Surg. 2007 Feb;33(2):287-92. doi: 10.1016/j.jcrs.2006.10.044.
PubMed 17276271Dewan T, Malik PK, Kumari R. Comparison of effective phacoemulsification time and corneal endothelial cell loss using 2 ultrasound frequencies. J Cataract Refract Surg. 2019 Sep;45(9):1285-1293. doi: 10.1016/j.jcrs.2019.04.015. Epub 2019 Jul 29.
PubMed 31371150Dewan T, Malik PK, Tomar P. Comparison of effective phacoemulsification time and corneal endothelial cell loss using three different ultrasound frequencies: A randomized controlled trial. Indian J Ophthalmol. 2022 Apr;70(4):1180-1185. doi: 10.4103/ijo.IJO_2163_21.
PubMed 35326010Liu Y, Jiang Y, Wu M, Liu Y, Zhang T. Bimanual microincision phacoemulsification in treating hard cataracts using different power modes. Clin Exp Ophthalmol. 2008 Jul;36(5):426-30.
PubMed 18939349Lundberg B, Jonsson M, Behndig A. Postoperative corneal swelling correlates strongly to corneal endothelial cell loss after phacoemulsification cataract surgery. Am J Ophthalmol. 2005 Jun;139(6):1035-41. doi: 10.1016/j.ajo.2004.12.080.
PubMed 15953433
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Surgical Procedures on Postoperative Outcomes in Cataract Phacoemulsification and Analysis of Related Factors
- ClinicalTrials.gov ID
- NCT07550907
- Acronym / sponsor ID
- IIT2025172
- Conditions
- Age-related Cataract
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 24 Apr 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.
The goal of this observational study is to evaluate the location of phacoemulsification tip measured by intraoperative OCT during cataract surgeries and its impact on early postoperative changes of cornea and visual acuity. The main question it aims to answer is:
In patients with age-related cataracts undergoing phacoemulsification, does the location (supracapsular, iris-lens diaphragm, or endocapsular) of the phaco tip affect postoperative corneal changes and visual acuity at early postoperative stage? Eyes having phacoemulsification for cataracts will receive intraoperative OCT imaging to evaluate the location of the phaco tip during surgery, and corneal changes and visual acuity will be measured postoperatively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phacoemulsification | – | Procedure: cataract surgery |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are planning to receive phacoemulsification combined with intraocular lens implantation for unilateral/bilateral age-related cataract
Key inclusion criteria (6 listed)
- Age ≥ 50 years and ≤ 90 years
- Diagnosis of unilateral/bilateral age-related cataract
- Nuclear grade ≥2 in LOCSIII classification
- Scheduled for cataract phacoemulsification combined with intraocular lens implantation
- Pupil size ≥6mm after dilation
Key exclusion criteria (4 listed)
- Diagnosis of severe systemic disease (e.g., severe hypertension or Alzheimer's disease)
- History of ocular trauma or surgery
- Presence of other ocular diseases (such as glaucoma, diabetic retinopathy, or high myopia)
- Other ocular factors that may complicate the surgery (such as small pupil, shallow anterior chamber)
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 |
|---|---|---|
| cataract surgeryCataract phacoemulsification combined with intraocular lens implantation | Procedure or surgery | Phacoemulsification |
Primary outcome
Change in corneal thickness
Time frame: postoperative day 1, week 1, and month 1
Corneal thickness measured by corneal endothelial specular microscope
3 secondary outcomes
Change in corneal endothelial cell density
Time frame: 1 day, 1 week, and 1 month postoperatively
Best-corrected visual acuity
Time frame: 1 day, 1 week, and 1 month postoperatively
Intraoperative and postoperative complications
Time frame: Intraoperative, 1 day, 1 week, and 1 month postoperatively
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 3 Jun 2026.
- Background: PubMed 37166786Liu Z, Lin H, Jin L, Qu B, Liu J, Zheng Y, He M, Luo L, Liu Y. Swab Pressing vs Stromal Hydration to Prevent Incision Leakage and Transient Collapse of Anterior Chamber in Phacoemulsification: A Randomized Clinical Trial. JAMA Ophthalmol. 2023 Jun 1;141(6):574-581. doi: 10.1001/jamaophthalmol.2023.1491.
- Background: PubMed 17276271Liu Y, Zeng M, Liu X, Luo L, Yuan Z, Xia Y, Zeng Y. Torsional mode versus conventional ultrasound mode phacoemulsification: randomized comparative clinical study. J Cataract Refract Surg. 2007 Feb;33(2):287-92. doi: 10.1016/j.jcrs.2006.10.044.
- Background: PubMed 31371150Dewan T, Malik PK, Kumari R. Comparison of effective phacoemulsification time and corneal endothelial cell loss using 2 ultrasound frequencies. J Cataract Refract Surg. 2019 Sep;45(9):1285-1293. doi: 10.1016/j.jcrs.2019.04.015. Epub 2019 Jul 29.
- Background: PubMed 35326010Dewan T, Malik PK, Tomar P. Comparison of effective phacoemulsification time and corneal endothelial cell loss using three different ultrasound frequencies: A randomized controlled trial. Indian J Ophthalmol. 2022 Apr;70(4):1180-1185. doi: 10.4103/ijo.IJO_2163_21.
- Background: PubMed 18939349Liu Y, Jiang Y, Wu M, Liu Y, Zhang T. Bimanual microincision phacoemulsification in treating hard cataracts using different power modes. Clin Exp Ophthalmol. 2008 Jul;36(5):426-30.
- Background: PubMed 15953433Lundberg B, Jonsson M, Behndig A. Postoperative corneal swelling correlates strongly to corneal endothelial cell loss after phacoemulsification cataract surgery. Am J Ophthalmol. 2005 Jun;139(6):1035-41. doi: 10.1016/j.ajo.2004.12.080.
- 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.
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-related Cataract, 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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 3 Jun 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in corneal thickness (time frame: postoperative day 1, week 1, and month 1). 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 NCT07550907, which also lists 6 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 3 Jun 2026.