CataractNCT07407049
Comparison of Early Postoperative Visual Acuity Between Intracapsular and Supracapsular Phacoemulsification: A Randomized Controlled Clinical Trial
A study testing Supracapsular Phacoemulsification and Intracapsular Phacoemulsification in people with Cataract, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
Cataracts are the leading cause of blindness worldwide, and phacoemulsification combined with intraocular lens implantation has become the most mainstream surgical approach. With advancements in surgical techniques and equipment, this procedure has evolved from a simple vision-restoring surgery into the era of… Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Cataract
- What is being tested?
- Supracapsular Phacoemulsification and Intracapsular Phacoemulsification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 24 Feb 2026to 31 Dec 2026
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 50 years and ≤ 90 years
- Able to cooperate with preoperative examinations
- At least one eye meets the study eye criteria
- Has the capacity and willingness to provide informed consent
- Age-related cataract
- Nuclear opacity (N) graded ≥4 according to the Lens Opacities Classification System III (LOCS III)
Show all 9Show fewer
- Scheduled for phacoemulsification with intraocular lens implantation
- Pupil size ≥6 mm after dilation
- Corneal endothelial cell density ≥1500 cells/mm²
Who cannot join
- Considered unsuitable by the investigator for participation in this clinical trial for other reasons (e.g., unstable systemic condition, uncontrolled blood pressure/blood glucose, severe cardiovascular disease, renal disease, etc.)
- Blood pressure > 180/110 mmHg (systolic >180 mmHg or diastolic >110 mmHg). Patients may be considered for inclusion if blood pressure can be controlled below these thresholds with medication.
- History of myocardial infarction or other cardiac disease requiring hospitalization, cerebral infarction, transient ischemic attack, or acute heart failure within 4 months prior to enrollment.
- Women with childbearing potential (i.e., currently pregnant, breastfeeding, or planning to become pregnant within the next 2 years). Women of childbearing potential should be asked about the possibility of pregnancy, and the investigator will determine when a pregnancy test is necessary.
- Currently participating in another clinical trial
- History of ocular trauma or surgery
- Presence of other ocular diseases (e.g., glaucoma, diabetic retinopathy)
- Other ocular factors that may complicate surgery (e.g., 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
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong
About this study
Cataracts are the leading cause of blindness worldwide, and phacoemulsification combined with intraocular lens implantation has become the most mainstream surgical approach. With advancements in surgical techniques and equipment, this procedure has evolved from a simple vision-restoring surgery into the era of refractive surgery. Patients now have higher expectations for postoperative visual quality, particularly the recovery of early vision, which directly impacts their satisfaction. Intraoperative surgical details have a direct influence on postoperative visual acuity.
Thanks to intraoperative optical coherence tomography (iOCT) technology, surgeons have gradually recognized that factors such as surgical incisions and intraoperative anterior chamber collapse can affect the survival of corneal endothelial cells after surgery, which is directly related to early postoperative vision and patient satisfaction. Swept-source intraoperative OCT (SS-iOCT) has further improved imaging range and clarity, helping us discover that the depth of intraoperative ultrasound energy use (such as cumulative dissipated energy) correlates with postoperative corneal endothelial cell loss. This suggests that compared to performing phacoemulsification at the capsular opening plane or in the anterior chamber, intracapsular phacoemulsification may reduce postoperative corneal endothelial cell loss, potentially leading to better early postoperative vision, which is crucial for patient satisfaction. However, evidence is still lacking.
Therefore, this study aims to compare the effects of intracapsular versus extracapsular phacoemulsification on early postoperative vision, as well as long-term visual acuity, corneal endothelial cells, corneal changes, and the incidence of intraoperative and postoperative complications.
- Conditions
- Cataract
- Being tested
- Supracapsular Phacoemulsification, Intracapsular Phacoemulsification
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supracapsular PhacoemulsificationProcedure or surgery
During phacoemulsification, real-time imaging of the anterior segment was performed using SS-iOCT (Tupai, China), but the surgeon was not able to view the images. The surgeon was instructed to proceed with phacoemulsification as per routine, using phaco energy (i.e., level 3). All other surgical steps were identical to conventional surgery.
Intracapsular PhacoemulsificationProcedure or surgery
During phacoemulsification, real-time imaging of the anterior segment was performed using SS-iOCT (Tupai, China). The surgeon was required to confirm under SS-iOCT guidance that the phaco tip was located within the capsular bag (as judged by two observers not involved in the surgery) before applying phaco energy (i.e., level 3). All other surgical steps were identical to conventional surgery.
| Study group | Role | What they receive |
|---|---|---|
| Supracapsular Phacoemulsification | Active comparator | Not described Receives: Procedure: Supracapsular Phacoemulsification |
| Intracapsular Phacoemulsification | Experimental | Not described Receives: Procedure: Intracapsular Phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
The best-corrected distance visual acuity at 1 day postoperatively.
It was evaluated using the ETDRS visual acuity chart by a masked optometrist, with the examination procedure following the standard ETDRS visual acuity testing protocol, and the unit of measurement was logMAR.
Measured: 1 day postoperatively
Secondary outcomes (6)
Coefficient of variation of corneal endothelial cell size
Measured: Post-operative day 1, week 1, month 1, month 3, month 6
The percentage loss of central corneal endothelial cell density compared to the preoperative baseline at post-operative day 1 and post-operative
Measured: 1 day and 1 month postoperatively
Percentage of hexagonal cells
Measured: Post-operative day 1, week 1, month 1, month 3, month 6
Central corneal thickness
Measured: Post-operative day 1, week 1, month 1, month 3, month 6
Corneal endothelial cell density
Measured: Post-operative day 1, week 1, month 1, month 3, month 6
The best-corrected distance visual acuity at other time frame
Measured: Post-operative week 1, month 1, month 3, month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start24 Feb 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407049
- Sponsor's protocol ID
- 2025KYPJ174
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Early Postoperative Visual Acuity Between Intracapsular and Supracapsular Phacoemulsification: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07407049
- Acronym / sponsor ID
- 2025KYPJ174
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 24 Feb 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Feb 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.
Cataracts are the leading cause of blindness worldwide, and phacoemulsification combined with intraocular lens implantation has become the most mainstream surgical approach. With advancements in surgical techniques and equipment, this procedure has evolved from a simple vision-restoring surgery into the era of refractive surgery. Patients now have higher expectations for postoperative visual quality, particularly the recovery of early vision, which directly impacts their satisfaction. Intraoperative surgical details have a direct influence on postoperative visual acuity.
Thanks to intraoperative optical coherence tomography (iOCT) technology, surgeons have gradually recognized that factors such as surgical incisions and intraoperative anterior chamber collapse can affect the survival of corneal endothelial cells after surgery, which is directly related to early postoperative vision and patient satisfaction. Swept-source intraoperative OCT (SS-iOCT) has further improved imaging range and clarity, helping us discover that the depth of intraoperative ultrasound energy use (such as cumulative dissipated energy) correlates with postoperative corneal endothelial cell loss. This suggests that compared to performing phacoemulsification at the capsular opening plane or in the anterior chamber, intracapsular phacoemulsification may reduce postoperative corneal endothelial cell loss, potentially leading to better early postoperative vision, which is crucial for patient satisfaction. However, evidence is still lacking.
Therefore, this study aims to compare the effects of intracapsular versus extracapsular phacoemulsification on early postoperative vision, as well as long-term visual acuity, corneal endothelial cells, corneal changes, and the incidence of intraoperative and postoperative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supracapsular Phacoemulsification | Active comparator | Procedure: Supracapsular Phacoemulsification |
| Intracapsular Phacoemulsification | Experimental | Procedure: Intracapsular Phacoemulsification |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 50 years and ≤ 90 years
- Able to cooperate with preoperative examinations
- At least one eye meets the study eye criteria
- Has the capacity and willingness to provide informed consent
- Age-related cataract
Key exclusion criteria (8 listed)
- Considered unsuitable by the investigator for participation in this clinical trial for other reasons (e.g., unstable systemic condition, uncontrolled blood pressure/blood glucose, severe cardiovascular disease, renal disease, etc.)
- Blood pressure > 180/110 mmHg (systolic >180 mmHg or diastolic >110 mmHg). Patients may be considered for inclusion if blood pressure can be controlled below these thresholds with medication.
- History of myocardial infarction or other cardiac disease requiring hospitalization, cerebral infarction, transient ischemic attack, or acute heart failure within 4 months prior to enrollment.
- Women with childbearing potential (i.e., currently pregnant, breastfeeding, or planning to become pregnant within the next 2 years). Women of childbearing potential should be asked about the possibility of pregnancy, and the investigator will determine when a pregnancy test is necessary.
- Currently participating in another clinical trial
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 |
|---|---|---|
| Supracapsular PhacoemulsificationDuring phacoemulsification, real-time imaging of the anterior segment was performed using SS-iOCT (Tupai, China), but the surgeon was not able to view the images. The surgeon was instructed to proceed with phacoemulsification as per routine, using phaco energy (i.e., level 3). All other surgical steps were identical to conventional surgery. | Procedure or surgery | Supracapsular Phacoemulsification |
| Intracapsular PhacoemulsificationDuring phacoemulsification, real-time imaging of the anterior segment was performed using SS-iOCT (Tupai, China). The surgeon was required to confirm under SS-iOCT guidance that the phaco tip was located within the capsular bag (as judged by two observers not involved in the surgery) before applying phaco energy (i.e., level 3). All other surgical steps were identical to conventional surgery. | Procedure or surgery | Intracapsular Phacoemulsification |
Primary outcome
The best-corrected distance visual acuity at 1 day postoperatively.
Time frame: 1 day postoperatively
It was evaluated using the ETDRS visual acuity chart by a masked optometrist, with the examination procedure following the standard ETDRS visual acuity testing protocol, and the unit of measurement was logMAR.
6 secondary outcomes
Coefficient of variation of corneal endothelial cell size
Time frame: Post-operative day 1, week 1, month 1, month 3, month 6
The percentage loss of central corneal endothelial cell density compared to the preoperative baseline at post-operative day 1 and post-operative
Time frame: 1 day and 1 month postoperatively
Percentage of hexagonal cells
Time frame: Post-operative day 1, week 1, month 1, month 3, month 6
Central corneal thickness
Time frame: Post-operative day 1, week 1, month 1, month 3, month 6
Corneal endothelial cell density
Time frame: Post-operative day 1, week 1, month 1, month 3, month 6
The best-corrected distance visual acuity at other time frame
Time frame: Post-operative week 1, month 1, month 3, month 6
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 12 Feb 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supracapsular Phacoemulsification and Intracapsular Phacoemulsification in people with 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 9 inclusion and 8 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 12 Feb 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 Zitian Liu (020-66610729, liuzt25@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The best-corrected distance visual acuity at 1 day postoperatively. (time frame: 1 day postoperatively). 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 12 Feb 2026.