Cataract SurgeryNCT03587909
FLACS vs Phaco in Shallow Anterior Chamber
A study testing Phacoemulsification Cataract SUrgery and Femtosecond Cataract Surgery in people with Cataract Surgery and Shallow Anterior Chamber, run by Iladevi Cataract and IOL Research Center at 1 site in India.
Trial summary
Phacoemulsification in eyes with a shallow anterior chamber (ACD < 2.2mm) presents with problems of safe access to the cataract and increased vulnerability of the endothelium and a higher tendency of complications such as descemet's detachment and iris prolapse. Read more about this study
- Who is it for?
- Ages 30 to 100 years
- Conditions the study is for
- Cataract Surgery, Shallow Anterior Chamber, Phacoemulsification
- What is being tested?
- Phacoemulsification Cataract SUrgery and Femtosecond Cataract Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2017to 15 Jan 2018
- 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 30 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- uncomplicated, age related cataracts
- Shallow anterior chamber (measured as </=2.5mm )
Who cannot join
- Coexisting ocular morbidity,
- inability to come for followup
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Performance and Postoperative Outcomes Following Femtosecond Laser Assisted Cataract Surgery (FLACS) and Manual Phacoemulsification in Eyes With Shallow Anterior Chamber
Phacoemulsification in eyes with a shallow anterior chamber (ACD < 2.2mm) presents with problems of safe access to the cataract and increased vulnerability of the endothelium and a higher tendency of complications such as descemet's detachment and iris prolapse. A shallow anterior chamber is also responsible for the high incidence of glaucoma and postoperative complications after cataract surgery. Femtosecond assisted cataract surgery has made cataract surgery safer and more predictable. The effective phacoemulsification time and intra-operative manipulation is greatly reduced in FLACS. However phacoemulsification still remains the most widely performed cataract surgery around the world. Post-operative outcomes after phacoemulsification in patients having shallow anterior chamber have been extensively reported in literature over the years.
There is no head to head comparison in terms of intraoperative performance and post-operative outcomes between FLACS and phacoemulsification in eyes with shallow anterior chamber.
Read more
The aim is to compare the intra-operative performance and post-operative outcomes in eyes undergoing femtosecond laser assisted cataract surgery versus eyes undergoing phacoemulsification in eyes having shallow anterior chamber.
The study will bring an understanding on the question: Do patients undergoing Femtosecond laser assisted cataract surgery behave differently from those undergoing phacoemulsification?
Read the detailed description
Inclusion Criteria:
- Age-related cataract
- Shallow Anterior Chamber (<2.5mm)
Exclusion Criteria:
-Ocular co-morbidity - corneal disorders, glaucoma, uveitis, previous ocular surgery
Surgical Technique :
- Standardized, Single Surgeon
- 2.2 mm clear corneal temporal incision
- FLACS Group : Capsulorhexis, Lens Fragmentation with femto laser
The investigators will be evaluating the following parameters:
- Primary outcome measure Corneal thickness on day 1, week 1 and 1 month (Change in corneal thickness of 15% from preop. will be considered significant).
- Secondary outcome measures
- Corneal clarity -on day 1, week 1 and 1 month postoperatively
- Anterior chamber cells and flare (Hogan's criteria)
- Percentage change in endothelial cell density from preoperatively to 3 months postoperatively
- Unaided visual acuity (distance) on day 1 and 1 month.
- Best corrected distance visual acuity 1 month postoperatively
- Other Observations :
- Cumulative Dissipated Energy (CDE) 2) Surgical time 3) Fluid used 4) Descemets membrane detachment during surgery 5) Incidence of iris trauma 6) Any other intra-operative complications
- Being tested
- Phacoemulsification Cataract SUrgery, Femtosecond Cataract Surgery
- Keywords
- FLACS, Phaco, Shallow Anterior Chamber
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phacoemulsification Cataract SUrgeryProcedure or surgery
Phacoemulsification in eyes with shallow anterior chamber (<2.5mm depth)
Femtosecond Cataract SurgeryProcedure or surgery
Femtosecond Cataract Surgery in eyes with shallow anterior chamber < 2.5mm
| Study group | Role | What they receive |
|---|---|---|
| Phacoemulsification Cataract Surgery | Active comparator | Procedure / Surgery : Phacoemulsification Surgery Receives: Procedure: Phacoemulsification Cataract SUrgery |
| Femtosecond Cataract Surgery | Active comparator | Procedure / SUrgery - Femtosecond Laser Cataract surgery Receives: Procedure: Femtosecond Cataract Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Corneal Thickness
Central Corneal Thickness
Measured: Postoperative Day 1
Secondary outcomes (2)
Anterior Chamber Inflammation
Anterior chamber cells and flare (Hogan's criteria)
Measured: Postoperative Day 1
Endothelial Cell Morphology
Endothelial Cell Density
Measured: Postoperative 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start1 Jan 2017
- Primary completion1 Dec 2017
- Study completion15 Jan 2018
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 Cataract SurgeryStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iladevi Cataract and IOL Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abhay R. Vasavada, Iladevi Cataract and IOL Research Center
- Investigators
- Abhay Vasavada, MS,FRCS, Principal investigator, Iladevi Cataract & IOL Research Centre, Ahmedabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03587909
- Sponsor's protocol ID
- FLACS1
- Status last verified
- Jul 2018
- First submitted
- 11 Jun 2018
- Last updated
- 16 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hung SH, Lan CH, Yao YH, Chiu TH, Lu DW, Chen YG, Yen WT. FLACS vs phacoemulsification in shallow anterior chambers: systematic review and meta-analysis. J Cataract Refract Surg. 2026 Sep 11. doi: 10.1097/j.jcrs.0000000000002062. Online ahead of print.
PubMed 42725767
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Performance and Postoperative Outcomes Following Femtosecond Laser Assisted Cataract Surgery (FLACS) and Manual Phacoemulsification in Eyes With Shallow Anterior Chamber
- ClinicalTrials.gov ID
- NCT03587909
- Acronym / sponsor ID
- FLACS1
- Keywords
- FLACS, Phaco, Shallow Anterior Chamber
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Iladevi Cataract and IOL Research CenterUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 16 Jul 2018 (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.
Phacoemulsification in eyes with a shallow anterior chamber (ACD < 2.2mm) presents with problems of safe access to the cataract and increased vulnerability of the endothelium and a higher tendency of complications such as descemet's detachment and iris prolapse. A shallow anterior chamber is also responsible for the high incidence of glaucoma and postoperative complications after cataract surgery. Femtosecond assisted cataract surgery has made cataract surgery safer and more predictable. The effective phacoemulsification time and intra-operative manipulation is greatly reduced in FLACS. However phacoemulsification still remains the most widely performed cataract surgery around the world. Post-operative outcomes after phacoemulsification in patients having shallow anterior chamber have been extensively reported in literature over the years.
There is no head to head comparison in terms of intraoperative performance and post-operative outcomes between FLACS and phacoemulsification in eyes with shallow anterior chamber.
The aim is to compare the intra-operative performance and post-operative outcomes in eyes undergoing femtosecond laser assisted cataract surgery versus eyes undergoing phacoemulsification in eyes having shallow anterior chamber.
The study will bring an understanding on the question: Do patients undergoing Femtosecond laser assisted cataract surgery behave differently from those undergoing phacoemulsification?
Detailed description
Inclusion Criteria:
- Age-related cataract
- Shallow Anterior Chamber (<2.5mm)
Exclusion Criteria:
-Ocular co-morbidity - corneal disorders, glaucoma, uveitis, previous ocular surgery
Surgical Technique :
- Standardized, Single Surgeon
- 2.2 mm clear corneal temporal incision
- FLACS Group : Capsulorhexis, Lens Fragmentation with femto laser
The investigators will be evaluating the following parameters:
- Primary outcome measure Corneal thickness on day 1, week 1 and 1 month (Change in corneal thickness of 15% from preop. will be considered significant).
- Secondary outcome measures
- Corneal clarity -on day 1, week 1 and 1 month postoperatively
- Anterior chamber cells and flare (Hogan's criteria)
- Percentage change in endothelial cell density from preoperatively to 3 months postoperatively
- Unaided visual acuity (distance) on day 1 and 1 month.
- Best corrected distance visual acuity 1 month postoperatively
- Other Observations :
- Cumulative Dissipated Energy (CDE) 2) Surgical time 3) Fluid used 4) Descemets membrane detachment during surgery 5) Incidence of iris trauma 6) Any other intra-operative 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 |
|---|---|---|
| Phacoemulsification Cataract Surgery | Active comparator | Procedure: Phacoemulsification Cataract SUrgeryProcedure / Surgery : Phacoemulsification Surgery |
| Femtosecond Cataract Surgery | Active comparator | Procedure: Femtosecond Cataract SurgeryProcedure / SUrgery - Femtosecond Laser Cataract surgery |
Who may qualify
- Ages
- 30 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- uncomplicated, age related cataracts
- Shallow anterior chamber (measured as </=2.5mm )
Key exclusion criteria (2 listed)
- Coexisting ocular morbidity,
- inability to come for followup
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 |
|---|---|---|
| Phacoemulsification Cataract SUrgeryPhacoemulsification in eyes with shallow anterior chamber (<2.5mm depth) | Procedure or surgery | Phacoemulsification Cataract Surgery |
| Femtosecond Cataract SurgeryFemtosecond Cataract Surgery in eyes with shallow anterior chamber < 2.5mm | Procedure or surgery | Femtosecond Cataract Surgery |
Primary outcome
Central Corneal Thickness
Time frame: Postoperative Day 1
Central Corneal Thickness
2 secondary outcomes
Anterior Chamber Inflammation
Time frame: Postoperative Day 1
Endothelial Cell Morphology
Time frame: Postoperative 6 months
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 16 Jul 2018.
- Derived from this study: PubMed 42725767Hung SH, Lan CH, Yao YH, Chiu TH, Lu DW, Chen YG, Yen WT. FLACS vs phacoemulsification in shallow anterior chambers: systematic review and meta-analysis. J Cataract Refract Surg. 2026 Sep 11. doi: 10.1097/j.jcrs.0000000000002062. Online ahead of print.
- 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.
Abhay Vasavada, MS,FRCS principal investigator
Iladevi Cataract & IOL Research Centre, Ahmedabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phacoemulsification Cataract SUrgery and Femtosecond Cataract Surgery in people with Cataract Surgery and Shallow Anterior Chamber, run by Iladevi Cataract and IOL Research Center at 1 site in India.
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 2 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: finished, as of the sponsor's last update on 16 Jul 2018. 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 India. 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?
Central Corneal Thickness (time frame: Postoperative Day 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 NCT03587909, 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 16 Jul 2018; AzTrials last refreshed its copy on 2 Nov 2026.